The model of study was single blinded randomized controlled clinical trial. This controlled trial used a parallel design where patients were allotted by implementation by 1:1 ratio in two groups(one experimental group as well as other control group).The trial is reported to the CONSORT 2010 statement (10). These patients had gone through a complete systemic physical examination, that includes the whole neurologic and musculoskeletal assessments and the following participants had excluded from the above study that had gone through the shoulder surgery, shoulder injury, history of trauma, shoulder joint dislocation A.C joint pathology, cervical radioculopathy and other systemic diseases. The patients who are diagnosed of having positive upper limb tension test (11) along with Neer (3) (4), Hawkins Kennedy (12) Empty Can (12), painful arc and cross body adduction test (13) can undergo the specific treatment to get desired results.
Randomization was performed by using computer generated random sequence table before the above assessment. Individuals, sequentially numbered index cards with the random assignment were prepared for treatment. The index cards were folded and placed in sealed and opaque envelopes. After the baseline examination, the participants were randomly assigned to receive routine physiotherapy or routine physiotherapy combined with neuromobilization.
One of the experienced staff members generated the random allocation sequence.
An independent assessor, who specialized in musculoskeletal injuries with more than five year experience of dealing patients with shoulder injury, was masked to the group for the allocation of the patients for treatment.
Eighty clinically analyzed patients of SIS had visited physical therapy department and enrolled for specific analysis. The study was described to all patients and informed consent was taken from them. This very consent process and form was approved by University Of Lahore Institutional Review Board before initial random selection of patients. These participants got admitted among patients who were visiting physiotherapy unit at Social Security Hospital Gujranwala.
The assessment of the patients occurred by a physiotherapist who had seven years long experience in his department by implementing previous history and examination. Demographic details, visual analogue scale (VAS) of pain and functional disability by University of California at Los Angeles rating score (UCLA) had been noted.
Aforementioned findings were kept hidden. Patients remained unnamed during the procedure. It was imparted information to them there were no harm of this given procedure it was further imparted they could discontinue it at any time during this procedure.
VAS was used to evaluate the severity of pain and it was considered as primary outcome of the specific study. A constant scale had been employed to inquire the patients about the shoulder pain during the activity and to classify it by indicating on a 10-mm line; it was connected “no pain” and the “worst pain you have ever felt”. This is common method of evaluating severity of pain. The given study findings have indicated that the VAS has high reliable as well as valid method to assess pain (14). UCLA score was assessed at base line, post treatment and after 1st follow up (15).
The patients were allocated into two groups; 1-Routine physiotherapy 2-Routine physiotherapy and NM. The patients have been under gone the treatment only for 3 times during a week which has been consisting of fifteen sessions. The patients were evaluated at baseline, after last treatment (5th week) and after 1st follow up (11th week). For ethical issues, as routine physiotherapy combined with NM group proved to get better results at the end of our interventions, we gave the control group with NM after the 1st intervention (16).
Routine Physical Therapy:
The routine Physiotherapy consisted of pulsed Short Wave Diathermy (SWD) with frequency 27.12 MHZ, Ultrasonic Therapy(US) with frequency 1.0 MHZ and intensity 1.45w/cm2 (17) and Transcutaneous Electrical Nerve Stimulator (TENS) 2-200 HZ with output current < 20Ma width 200µ seconds along with continuous mode. Exercises comprised were shoulder strengthing and stretching exercises were performed for 5 sec with 10 repetitions (18). See exercises in Table-II
Mechanical management may therefore be used to augment physiology in the nervous system. NM sequencing is the activity of set of specific component of body movements so as to get particular mechanical events in the nervous system, which is to that specific of component movements (5).NM was applied by using Butler’s recommendations (19).
Initially, the patient performed neural sliders and gradually progressed to neural tensioners. Neural sliders consisted of cervical lateral flexion movement, toward the involved side, simultaneously with elbow flexion and extension movements. While moving the head in to cervical lateral flexion the elbow was extended. When the elbow began to flex, the cervical spine was returned to neutral position. Neural tensioners are performed to create tension in the nerve to get the desired results. The tension position is not held for a length of time, but is released by extending the elbow and returning the cervical spine to neutral. Once the patient had pushed slight pain or discomfort at any point (20). NM technique was performed for 5 sec with 10 repetitions to control the pain and improve the functional disability score to relive the pain. See table-II
Patients were assessed at baseline, after post treatment (5th week) and after 1st follow up (11th week) on VAS pain scale (0 no pain 10 maximum pain). (14) Pain was considered as primary outcome.
UCLA score was assessed at baseline, on post treatment (5th week) and at 1st follow up (11th week) (15). UCLA score was considered as secondary outcome.
Sample size calculation was derived from Abeer A et al’s paper (21).
According to clinical trials, the sample size estimation formula was implemented (22).
Where SD= Standard deviation=14.08, Z 1-α/2 is type 1 error=1.96, Zβ=0.84, d=µ2-µ1=10.7.
Based on this a total sample size of around 80(experimental = 40, controls = 40) was calculated to be an adequate mean to reach the conclusion.Considering a loss of 20% follow-up, at least 80% patients followed the treatments (23). An experimental group and a control group were recruited which were based on the inclusion criteria for this study (Figure. 1). Both the groups of patients were selected by regularly visiting the physiotherapy department at Social Security Hospital Gujranwala.
The data were analyzed by using SPSS 22.0 programme.
Qualitative data was presented in frequencies and percentages while mean and S.D was calculated for Quantitative data. Line chart was drawn at various times in weeks during the treatment vs pain score and UCLA score.
Repeated measure ANOVA was applied among both the group to compare average pain and UCLA score different times (baseline, 5th week, 11th week). The confidence level of 95% was used as well as p value ≤ 0.05 was considered as significant.
Primary outcome analysis
Repeated measure ANOVA was applied among both the groups to compare the average pain score different times (baseline, 5th week, 11th week).The confidence level of 95% was used as well as p value ≤ 0.05 was considered as significant.
Secondary outcome analysis
UCLA was identified as secondary outcome. Repeated measure ANOVA was applied among the groups to compare the average UCLA score different times (baseline, 5th week, 11th week). The confidence level of 95% was used as well as p value ≤ 0.05 was considered as significant.