The use of neurodynamic mobilization in patients with cervical spondylotic radiculopathy: in mild pain or pain-free range? A randomized controlled trial

doi:10.21203/rs.3.rs-1613012/v1

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The use of neurodynamic mobilization in patients with cervical spondylotic radiculopathy: in mild pain or pain-free range? A randomized controlled trial

https://doi.org/10.21203/rs.3.rs-1613012/v1

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Background Cervical spondylotic radiculopathy is commonly seen nowadays, and neurodynamic mobilization is believed to be effective in treating this condition. However, the ideal degree of neurodynamic mobilization is still unknown. The aim of this study was to investigate the effect of different neurodynamic mobilization intensity in treating cervical spondylotic radiculopathy.

Methods Forty patients with cervical spondylotic radiculopathy were included and randomly allocated into pain-free mobilization group or the mild pain mobilization group. Interventions included conventional rehabilitation therapy plus pain-free or mild pain neurodynamic mobilization, with two sessions/day for five days. The outcome measurements included VAS pain scale, neck range of motion, and Vernon-Mior neck disability index, at baseline before, immediate after treatment, and 1-, 2-, and 4-weeks post treatment as follow-ups.

Results Baseline comparison showed no group differences (P > 0.05). Significant differences were found before the intervention and 4 weeks after the treatment in all outcome measures (p <0.05) in both groups. While there were no significant differences between groups after treatment, the outcome measures in the mild pain group were slightly better than the pain-free group.

Conclusions This was the first study to evaluate neurodynamic mobilization based on pain intensity rather than different ranges of motion. A new classification of neurodynamic mobilization was proposed in this study. Clinicians can use this classification as reference, combining their own clinical reasoning, clinical experiences and patient’s responses to guide the decisions when choosing neurodynamic mobilization technique.

Trial registration

This study was registered on the Chinese Clinical Trial Registry, with the number of ChiCTR2000031842 on 12/04/2020.

neurodynamic mobilization

neck pain

cervical spondylotic radiculopathy

Cervical radiculopathy, used to describe abnormal sensory or motor conditions caused by irritation or compression of root of cervical nerve with radiating symptom on upper extremity, is commonly seen nowadays ^{[1, 2]}. Abnormal postures, lifestyles, work environment, habits and hobbies, sex, and age can all contribute to compression or irritation of cervical nerves. Those factors may influence sensory or motor roots, causing symptoms including pain, numbness or a decrease in motor or sensory control ^[2–4]. The potential causes are mostly considered as nerve root compression, protrusion of intervertebral disc, or the stenosis of the intervertebral foramen ^[5–7]. The symptoms vary based on the severity and duration of compression.

Cervical spondylotic radiculopathy (CSR) is one type of cervical radiculopathy, with a pathogenesis of degenerative changes influencing discs, the posterior part of facet joints as well as bone hyperplasia^[3]. There are two types of treatment commonly used for CSR, including the surgical treatment and the conservative treatment. Specifically, for the conservative treatment, manipulation, physical agents, traction, and neurodynamic mobilization are mostly used and are proved effective^{[8, 9]}.

Neurodynamic mobilization, which is considered one of the manual therapies, has been suggested useful for the positive effect in several studies^{[10, 11]}. Recent studies confirmed the effectiveness of neurodynamic mobilization in treating cervical spondylotic radiculopathy and found significant improvement in pain and disability post treatment^[12–15].

Some studies suggested that neurodynamic mobilization may reduce pain by improving the blood supply and nerve nutrition, resulting in inflammation and edema reduction^{[16, 17]}. Other studies also mentioned movement between the nerve system and the surrounding tissues^[18] can relieve pain and reduce irritability for CSR patients. Due to the reduction of pain severity and irritability, individuals could regain normal motor patterns and controls, and therefore, more functional training can be obtained ^{[10, 19, 20]}.

Reasonable intensity of mobilization is an important basis for effective treatment. The intensity of treatment is based on the response of patients and the therapist’s feeling.

There are a few small sample-sized studies used pain-free range mobilization and supported the use of this technique^{[13, 21]}. However, the optimal mobilization range still needs to be explored due to the lack of high-quality randomized controlled trials ^[22–24].

A complete pain-free range is hard to accomplish since mild pain is inevitable in actual mobilization. Hence, physical therapists aim at performing neurodynamic mobilization in mild pain range during clinical practice. However, it is unknown whether a mild pain range mobilization will cause damage to the rehabilitating tissue. Therefore, this study aimed to compare the effect of neurodynamic mobilization in pain-free and mild pain range for patients with cervical spondylotic radiculopathy. And we aimed to explore the optimal range of manipulation to provide reference for clinical practice. Our hypothesis is that both mobilization techniques would be beneficial, but mobilizing in a pain-free range may restrict the therapeutic effect due to the limited intensity to achieve a greater range of motion.

Design

This was a 2-armed parallel randomized controlled trial for patients with cervical spondylotic radiculopathy accompanied with symptoms including neck pain, numbness, radiating symptoms on the upper extremity, etc.

Before starting this trial, we classified the technique into four categories, including pain-free, mild pain, pain and mobilization under anesthesia (MUA). For pain-free technique, therapists mobilized within physiological range and would not reach either the pain trigger point nor the stiffness point, so patients won’t feel any discomfort. For mild pain technique, it was performed under mild pain (Visual Analogue Scale; VAS score ≤ 3) that can be tolerated, and the discomfort would gone immediately once the force was removed. For pain group, a pain intensity of VAS score at 4 to 6 would be reached, and usually accompanied with upper extremity avoidance behaviors during mobilization with more soft tissue damages compared with mild pain group, which usually required dozens of minutes to recover. While for the MUA, techniques were conducted under anesthesia. In this study, we selected the first two categories, pain-free and mild pain, for further examination, which were more common in practice.

Participants

Participants were recruited in inpatient and outpatient departments from August 1st to July 31th in 2021. The inclusion criteria were: (1) patients diagnosed with cervical spondylotic radiculopathy with symptoms of neck pain accompanying with radiating symptoms and with diagnostic imaging confirmation; (2) patients aged between 18 and 60 years old; (3) patients with pain severity screened by VAS score ≥ 4/10; (4) patients who demonstrated positive results in nerve tension test and responded positively when applying the neurodynamic mobilization techniques; (5) patients agreed and provided written consent for treatment and follow-up process.

The exclusion criteria were: (1) patients who have been diagnosed with other diseases; (2) patients confirmed with serious neuro-psychological problems, such as Parkinson’s disease, stroke, anxiety, etc.; (3) patients have currently or already undergone any type of pain treatments like nonsteroidal anti-inflammatory drugs (NSAIDs), which may blind the pain severity; (4) patients participated in other physiotherapeutic treatment in last 3 months.

Sample size

G-power software was used for the calculation process. The sample size was calculated by the VAS scale, the primary outcome measure. According to previous research, t test was used for computer required sample size to achieve statistical power of 80%. Assuming an α error of 0.05, and the allocation ration of group 1/ group 2 was 1. Assuming a standard deviation of 9.8, and a mean difference of 10. 40 participants (20 per arm) were recruited in total.

Randomization and allocation concealment

participants were randomized into either pain-free group or mild pain group, and for each group, the number of patients was identical.

The randomization was performed by a statistician using the SPSS 22.0 computer-generated random numbers table, and each group included 20 individuals.

Before receiving treatment, participants were explained the neurodynamic mobilization in detail by researchers responsible for this study. Eligible participants were allocated to either group at the ratio of 1:1 by sealed envelopes.

Blinding

As participants and therapists performing the intervention were impossible to be blinded due to the classification of mobilization grades that was based on patients’ feedback, which cannot satisfy the blinding process of patients. And therefore, the blinding process was only performed in researchers who were responsible for patient evaluation and statistical analysis.

The evaluation was performed by the same evaluator throughout the whole program. Computerized statistics didn’t include any information relating to patients' allocation in either group.

Intervention

All participants with cervical spondylotic radiculopathy were examined both through imaging and functional tests to ensure they met the eligibility criteria. Each group received manual therapy, including joint mobilization, myofascial release technique, cervical distraction, and neurodynamic mobilization, together with modalities targeting patients’ pain or other symptoms if necessary. The patients were administered for a total of 10 sessions, twice a day for 5 days.

For the pain-free group, gliding technique was applied, and no increases in pain level was noticed while operating. The pain free group were mobilized under the physiological range where the patient feels no discomfort in the motion. Additionally, the mobilization never reached either the pain trigger point or the stiffness point, making sure the safety of tissues during the operation.

As for the mild pain group, using similar gliding technique mentioned above, the mobilization was performed under the range of a mild increase in pain that can be tolerated (≤ 3 scores on VAS scale), and the discomfort can get released immediately once the force was removed. When reaching the pain trigger point or stiffness point, a small range of mobilization was applied, which might increase the range of motion accompanied by some micro damages, such as small soft tissue injury. The neurodynamic mobilization of both groups were performed 6–8 repetitions per set, with 3 sets per session, two sessions per day, and after each set, a one-minute pause for a break was given, and patients' reactions towards treatment were asked and recorded^{[10, 25]}.

Outcome measures

Clinical outcomes were measured before the treatment, right after the treatment, and followed up for 1, 2, and 4 weeks after the treatment, with primary outcome measurement of the VAS scale. Secondary outcomes included the cervical range of motion and Vernon-Mior neck disability index (NDI).

Pain severity was regarded as one of the most meaningful indexes and was evaluated by the VAS scale. The pain intensity was measured on a 10 cm line, on which patients were asked to place a mark on the line representing their pain level, where 0 indicated pain-free and 10 indicated the maximum pain level. Particularly, 0–3 represented mild pain, 4–6 represented moderate pain, and 7–10 represented severe pain; patients score 7 and above also suggested the difficulty of sleep due to neck pain^{[20, 26]}. The minimal clinically important difference of this scale was considered 1.3 points based on a previous study reported by Cleland et al.^[27].

Apart from the pain level, Vernon-Mior neck disability index (NDI) was a measurement to assess patients' functional disability resulting from neck pain. It contained 10 items, including pain, concentration, headache, and functional activities (personal care, lifting, sleeping, recreation, reading, driving, and work). Scores for each item range from 0 to 5, and the higher the scores were, the more severe the disability will be. The self-reported scale was considered the most valid and reliable as a responsive clinical tool. The test-retest reliability for cervical radiculopathy was reported fair (Intraclass correlation coefficient (ICC) = 0.55) to moderate (ICC = 0.68)^{[20, 28, 29]}.

Statistical analysis

SPSS 22.0 was used for statistical analysis. After examining for normal distribution, a two-way repeated measure ANOVA (two-tailed) was used between groups and within subjects for all outcome measures. Variables before treatment, immediately after treatment, and 1, 2, 4 weeks after treatment were analyzed. T test was used to compare baseline data between groups.

Primary outcomes between pain free group and mild pain group were used for effect size’s demonstration and evaluation. And more specifically, 0.2 represents a small effect size, 0.5 represents mediate and 0.8 represents large size. An approach of intentional treatment was used for the main comparative analysis with primary and secondary outcomes. A sensitive analysis was made for documenting missing data with a significance level of 0.05.

A total of 76 patients were recruited in the first place, and 27 were excluded due to the ineligibility of inclusion criteria. During the 1-week treatment, three dropped out because of the loss of follow-up, and the other six required discontinuing the treatment due to personal reasons (Fig. 1.). Totally there were 40 participants (21 males and 19 females, 42.2 ± 10.0 years old) completed the whole program, and the data were collected thoroughly.

A random number table was used for allocating patients into pain-free group or mild pain group. Baseline parameters for two groups were presented in Table 1, and no significant differences were found between groups.

Table 1

Baseline information and comparisons between groups
		Pain-free (20)	Mild pain (20)	P-value
Sex (women/men)		9/11	10/10	> 0.05
Age (mean ± SD)		44.05 ± 13.11	40.30 ± 9.96	> 0.05
VAS before (mean ± SD)		5.55 ± 1.72	5.15 ± 1.39	> 0.05
ROM (degree)				> 0.05
	flexion (F)	31 ± 13.29	32.75 ± 14.87	> 0.05
	extension (E)	28 ± 18.73	26.25 ± 16.23	> 0.05
	left flexion (LF)	27.75 ± 9.93	30 ± 9.87	> 0.05
	right flexion (RF)	27.25 ± 11.67	28.75 ± 12.23	> 0.05
	left rotation (LR)	39.50 ± 18.90	33.75 ± 19.10	> 0.05
	right rotation (RR)	37.25 ± 22.11	35.25 ± 19.66	> 0.05
NDI		16.65 ± 6.30	15.8 ± 5.94	> 0.05
SD: standardized deviation; VAS: Visual Analogue Scale; ROM: range of motion; NDI: Vernon-Mior neck disability index
Data were provided as means and SD for variables, and analysis of variance was used for continuous variables.

At the end of each treatment session, clinical results were recorded timely including pain severity, range of motion, and NDI index. Table 2 presented outcome measures for pain-free group while Table 3 presented outcome measures for mild pain group. In both groups, the comparisons between before and after treatment showed a significant difference (P < 0.01). As presented in Table 4, although no statistical significance was found between groups in all parameters 4 weeks after treatment, the clinical outcome for mild pain group were slightly better than in pain-free group. This was also illustrated in Fig. 2 (a-b) (pain severity: mild pain group: 0.78 ± 0.66, pain-free group: 0.95 ± 0.85; NDI: mild pain group: 1.7 ± 1.93, pain-free group: 1.75 ± 2.62) 4 weeks post treatment. A downward trend was found for pain intensity and NDI score while the ROM demonstrated an upward trend (Fig. 3 (a-h)).

Table 2

Outcome measures for pain-free group
		Before	After	1 week	2 weeks	4 weeks	P-value
VAS		5.55 ± 1.72	3.45 ± 2.04	2.50 ± 1.60	1.35 ± 1.10*	0.95 ± 0.85*	<0.01
ROM
	F	31 ± 13.29	35.75 ± 12.87	38.75 ± 9.20	43.25 ± 9.73*	44 ± 14.31*	<0.05
	E	28 ± 18.73	35.75 ± 20.57	41.75 ± 18.73	48.25 ± 14.50*	53.75 ± 14.31*	<0.01
	LF	27.25 ± 9.93	31 ± 9.70	36.25 ± 6.87	43.25 ± 11.10	42.25 ± 4.32	<0.05
	RF	27.25 ± 11.67	31.25 ± 10.83	36.75 ± 6.18	41.75 ± 11.65	40.25 ± 6.22	<0.05
	LR	39.25 ± 18.90	46.25 ± 20.00	52 ± 17.91	60 ± 13.13*	67 ± 12.88	<0.01
	RR	37.25 ± 22.11	45.5 ± 21.38	52.25 ± 17.64	58.5 ± 14.5*	65.25 ± 13.79	<0.01
NDI		16.65 ± 6.30	NA	6.7 ± 5.61	3.15 ± 3.80*	1.75 ± 2.62*	<0.01
*: statistically significant within groups
Data are provided as means and SD.

Table 3

Outcome measures for mild pain group
		Before	After	1 week	2 weeks	4 weeks	P-value
VAS		5.15 ± 1.39	3.88 ± 1.77	2.3 ± 1.27	1.15 ± 0.91*	0.78 ± 0.66*	<0.01
ROM
	F	32.75 ± 14.87	35.25 ± 14.10	39.25 ± 9.78	41.25 ± 9.47*	44.5 ± 6.5*	<0.05
	E	26.26 ± 10.23	36 ± 18	44.75 ± 7.46	50.75 ± 13.44*	56 ± 13.75*	<0.05
	LF	30 ± 9.87	31 ± 9.76	36.5 ± 8.23	41.5 ± 5.5*	42 ± 5.34	<0.05
	RF	28.75 ± 12.23	30 ± 11.51	35.75 ± 7.46	39 ± 6.63*	39.25 ± 6.76*	<0.01
	LR	33.75 ± 19.09	40.25 ± 21.53	51.75 ± 16.98	61.25 ± 12.83*	69.75 ± 11.78	<0.01
	RR	35.25 ± 22.66	42.25 ± 20.94	51.25 ± 18.09	59.25 ± 15.91*	68.75 ± 13.31	<0.01
NDI		15.8 ± 5.94	NA	6.2 ± 4.19	2.8 ± 3.12	1.7 ± 1.93	<0.05
*: statistically significant within groups
Data are provided as means and SD.

Table 4

Outcome measures comparison between groups (4 weeks after treatment)
		pain-free	mild pain	P-value
VAS		0.95 ± 0.85	0.78 ± 0.66	> 0.05
ROM				> 0.05
	F	44 ± 14.31	44.5 ± 6.5	> 0.05
	E	53.75 ± 14.31	56 ± 13.75	> 0.05
	LF	42.25 ± 4.32	42 ± 5.34	> 0.05
	RF	40.25 ± 6.22	39.25 ± 6.76	> 0.05
	LR	67 ± 12.88	69.75 ± 11.78	> 0.05
	RR	65.25 ± 13.79	68.75 ± 13.31	> 0.05
NDI		1.75 ± 2.62	1.7 ± 1.93	> 0.05
Data are provided as means and SD.

In the pain-free group, significant differences (P < 0.05) were found in cervical flexion, left flexion, and right flexion, and P < 0.01 were found in VAS score, extension, left rotation, right rotation, and NDI score four weeks after treatment. Particularly, follow-ups showed no significant difference for left and right flexion after 1 week (P_LF=0.514, P_RF=0.844), and no difference for left and right rotation after 2 weeks (P_LR=0.101, P_RR=0.173). In fact, left flexion, left and right rotation was shown no difference after 2 weeks of treatment (P_LF=0.224, P_LR=0.91, P_RR=0.85), and NDI index shown no difference after 1 week of treatment (P = 0.357).

However, in the mild pain group, a significant difference was found in all indexes after 4 weeks. And a significant increase was found in the left flexion range (Fig. 3d) and left and right rotation range (Fig. 3(f-g)) 1 week after treatment in mild pain group.

Adverse event

No adverse event was documented at any stage. No significant increase of symptoms was reported after each treatment session.

In recent study of neurodynamic mobilization, completing the mobilization in pain-free range is recommended to avoid other tissue lesions ^[10]. However, mild pain range is more likely to happen in real-life operations. But there are no other studies comparing effects between pain-free and mild pain range.

Our research compared the effect of different intensities of neurodynamic mobilization on pain intensity, functional status and range of motion. These indexes provided tools for assessing potential risks and therapeutic effects. Based on this study, participants demonstrated improved symptoms and functions in both pain-free group and mild pain group after treatment. Our study showed positive results for all participants, and our speculation is that we only recruited patients who responded positively to neurodynamic mobilization, which was a crucial factor to guarantee the program and more suitable for our research of different intensities of neurodynamic mobilization.

A study compared active and passive neurodynamic mobilization and discovered that this technique was effective in pain relief, neck range of motion and functional outcomes^[13]. To our best knowledge, there was only one protocol mentioning mobilization range related to different intensities. Giovanni et al. ^[30] conducted the study protocol of neuro-mobilization for treatment of nerve-related pain under mild pain range and defined mild pain mobilization as an increase in numbness or tingling with VAS ≥ 2 points. However, this article only raised a study protocol, no further data were found.

Another study^[31] compared pain-free group and pain-threshold group to discover optimal range of manual therapy for rehabilitation of acute hamstring strain injury. The study suggested that although no acceleration was discovered in return-to-play clearance, muscle strength and fascicle length were better maintained in pain-threshold group. However, no detailed classification of manual therapy regarding pain intensity has ever been further defined in this study. Furthermore, no further data indicated the optimal range of manual therapy or mobilization, considering the outcome measures (pain severity, functional status, ROM and activities of daily living) mentioned in previous studies^{[23, 30, 32]}.

Thus, in this study, we proposed a new category standard, which classified mobilization degrees based on patients’ feedback subjectively (Table 5). Different from the previous classifications which were based on the range of mobilization, this one provided a vision from patients rather than therapists, which we expected to have a more precise mobilization and to reach a better clinical result. It also demonstrates the value of patient-centered care.

Table 5

New classification of neurodynamic mobilization based on pain intensity
Degree	Mobilization degree	Pain severity (VAS scale)	Degree indication
1	Pain-free	0	No pain or discomfort
2	Mild pain	< 3	Tolerable and pain decreases immediately as mobilization ended
3	Pain	4–6	Extremity avoidance or resistance behaviors can happen during mobilization; requires dozens of minutes to recover
4	Excessive pain	> 7	Significant avoidance or resistance behaviors happen with tissue lesion; anesthesia needed

This study has some strengths. Firstly, a detailed classification of neurodynamic mobilization based on pain intensity has been defined and proposed in this study, providing a reference of neurodynamic mobilization intensity for clinical use. Secondly, this was the first study to analyses the effect of different degrees of neurodynamic mobilization on cervical spondylotic radiculopathy patients, which could provide new idea for future study. However, there were also some limitations of this study. Firstly, only two subgroups were allocated, which cannot tell how other mobilization degrees would influence clinical results. We believe that further studies should compare neurodynamic techniques under several different pain intensities to further understand the effect of different degrees of neurodynamic mobilization. Secondly, the follow-up periods were limited, which was a restriction to explore the long-term effects. Thirdly, the result may be influenced by patients’ feedback due to their subjective feeling towards different pain severity. Moreover, in this study, different range of mobilization showed no significant difference in clinical outcome, this may due to the small sample size of 40 participants. A larger sample size of study can be carried out in the future.

A significant decrease in pain and increase in functional outcomes have been observed in both groups, suggesting the effectiveness of neurodynamic mobilization for patients with cervical spondylotic radiculopathy. Although the pain-free group and mild pain group didn’t show the statistical difference, a slightly better clinical outcome was found in mild pain neurodynamic mobilization group. A new classification of neurodynamic mobilization based on pain intensity has been proposed by the study, which might guide clinical decisions for patients with cervical spondylotic radiculopathy.

CSR

Cervical spondylotic radiculopathy

MUA

Mobilization under anesthesia

VAS

Visual Analogue Scale

NDI

Vernon-Mior neck disability index

Ethic approval and consent to participate

This study was approved by the Biomedical Ethics Committee of West China Hospital of Sichuan University on 21 July 2020, with approval number 1194. All methods were carried out in accordance with relevant guidelines and regulations. And the informed consent was obtained from all subjects.

Consent for publication

Not applicable.

Availability of data and materials

All data generated or analyzed during this study are included in this published article.

Competing interest

The authors declare that they have no competing interests

Funding

This study is funded by Sichuan Science and Technology Agency (2019YJ0130). And the funding supported for the data analysis and interpretation.

Author contributions

YMK have given substantial contribution to the manuscript. WZ and YHL contributed to data collection and analysis, CBY contributed to data analysis. LJ and YL revised the manuscript and approved the final version.

Acknowledgement

The authors would like to thank West China Hospital Sports Medicine Center and Institute of Rehabilitation for this research.

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No competing interests reported.

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The use of neurodynamic mobilization in patients with cervical spondylotic radiculopathy: in mild pain or pain-free range? A randomized controlled trial

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Randomization and allocation concealment

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Outcome measures

Statistical analysis

Results

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Discussion

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