Study setting {9}
The study will be conducted in a rheumatology and family medicine clinic in Colombo, Sri Lanka.
Eligibility criteria {10}
Study inclusion and exclusion criteria are described in Table 1.
Table 1
Inclusion and Exclusion criteria.
Inclusion criteria | Exclusion criteria |
• Patients affected with chronic (> 12 weeks) neck and shoulder region pain attending the four clinics managed by the same physician and physiotherapist. | Patients affected with infections, inflammatory arthropathies, malignancies, Alzheimer’s disease, psychiatric conditions, severe depression and anxiety will be excluded. |
• Patients affected with mechanical causes such as degenerative changes of the spine, muscle strain, ligament sprain. | Patients who take part in yoga and other meditation programmes. |
• Patients who can understand and communicate in Sinhala. | Patients who are below the age of 18 years and above the age of 65 years. |
Who will take informed consent? {26a}
The corresponding author will collect written informed consent from the participants after explaining the details of the study to them.
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Not relevant
Interventions
Explanation for the choice of comparators {6b}
Not relevant
Intervention description {11a}
This study consists of three intervention groups and a control group. Each intervention group will be practicing a different meditation technique for eight weeks in addition to usual care. The control group will follow only usual care. The three different types of meditation techniques are:
- Metta (concentration on loving kindness) [19].
In Anapana meditation, the attention is on ‘the breath’ and it focuses on ignoring any distractions that might break the chain of awareness on ‘the breath’. It helps to keep away thoughts of cravings, aversions, fantasies and illusions [8].
In Body scan meditation the meditator observes bodily sensations in a systematic manner from head to feet and from feet to head; by not reacting to them it helps the meditator to realise the impermanent nature of these sensations and consequently, this will help the meditator to get rid of thoughts of cravings and aversions [8].
Practicing Metta type of meditation helps to remove thoughts of anger and hatred from the mind and introduce thoughts of patience, friendship and love [20].
The meditation techniques will be taught to the patients by a meditation trainer who has more than ten years of experience in teaching meditation. Meditation techniques will be taught on a weekly basis for eight weeks. Each session will include five patients and last for 30–45 minutes [9]. In between weekly training sessions, patients in the intervention groups will be requested to practice the meditation technique that was taught to them, for fifteen minutes each day. They will be advised to only practice the meditation technique that was taught to them and not to practice any other technique. Participants will be requested and instructed in keeping a logbook record of their daily meditation practice. They will be requested to log the duration of each practice session. Additionally, using a numerical pain rating scale [21], they will be requested to log the pain intensity ratings from the previous 24-hours corresponding to:
Participants will also be requested to log the type, dose and amount of medication taken each day.
Criteria for discontinuing or modifying allocated interventions {11b}
Participants will not be subjected to any pain or harmful interventions. Therefore, we do not feel that there will be a necessity to modify the allocated intervention.
Strategies to improve adherence to interventions {11c}
Daily short message services (SMS) will be sent to participants reminding them to practice their allocated meditation and to complete their log book. Weekly face-to-face meditation training sessions with the meditation trainer will also be used to address any concerns or difficulties experienced by participants.
Relevant concomitant care permitted or prohibited during the trial {11d}
Participants in the intervention groups will be asked not to take part in any meditation or yoga programmes other than their allocated meditation intervention. Participants in the usual care group will also be requested not to take part in any meditation programmes or yoga during the eight-week intervention period of the trial. Additionally, participants will be advised not to engage in treatment for their neck and shoulder region pain, other than from the physician or therapist in the registered clinic as part of the trial.
Provisions for post-trial care {30}
No harmful procedures will be conducted during the trial. Therefore, it is unlikely that the participants will need post trial care. If by chance the participants need any care they will be referred to the appropriate specialist.
Outcomes {12}
Primary and secondary outcomes are stated in Table 2.
Table 2
Primary and Secondary Outcomes
Primary Outcome | Secondary Outcomes |
Compare the three intervention groups with usual care group and with each other with regard to differences in changes in pain in the neck and shoulder region at eight weeks follow-up. | (i) Compare the three intervention groups with usual care group and with each other with regard to differences in changes in pain in the neck and shoulder region at four and twelve weeks follow-up. |
| (ii) Compare the three intervention groups with usual care group and with each other with regard to differences in changes in the pain free range of movement in the neck and shoulder region at four, eight and twelve week follow-up. |
| (iii) Compare the three intervention groups with usual care group and with each other with regard to differences in changes in quality of life with regard to activities of daily living, occupation and social activities with family and friends at four, eight, and twelve weeks follow-up. |
| (iv) To determine how patients in the three intervention groups feel about the effects of meditation on pain, physical and social disability with regard to activities of daily living, occupation and social activities with family and friends at eight weeks follow-up. |
Participant timeline {13}
The duration of the trial is twelve weeks and the supervised intervention duration is eight weeks. The participants will be assessed at baseline and four, eight and twelve weeks follow up.
Sample size {14}
Sample size was calculated using the WinPepi version 11.65 statistical software. Results from a study by Jeitler et al. (2015) with patients with chronic neck pain were used to calculate the sample size [11]. This study used a numerical pain rating scale, similar to the one proposed for the current study. After eight weeks of Jyoti meditation training, improvements in pain intensity rating in the intervention group compared to the control group were 17.8. Using this improvement value of 17.8, a power of 80%, and a ratio of 1:1, the sample size calculation for each cluster (clinic) was n = 19. Therefore, the total sample in our study will be n = 76. In an RCT conducted by Rantonen et al. (2018) involving three intervention groups and a control group the dropout rate was 26% [22]. Therefore, our total study sample size, after accounting for this rate of dropout will be n = 96; evenly spread across each group allocation, resulting in 24 participants per group.
Recruitment {15}
All patients who are not currently being treated for neck and shoulder pain in this clinic who meet the eligibility criteria and who attend the clinic on one of the intervention clinic days will be notified about the research study by an independent person (nurse). Patients who show their willingness to participate will be provided more information about the project and their written consent will be obtained prior to recruitment.
Assignment Of Interventions: Allocation
Sequence generation {16a}
Since this is a cluster clinic-based trial, participants will be randomised according to the clinic day rather than individually.
Concealment mechanism {16b}
The person who assesses the outcomes will be blinded to the group allocation.
Implementation {16c}
Implementation will be done by the researchers. Participants will be assigned to intervention groups and the control group by a clinic nursing assistant.
Assignment Of Interventions: Blinding
Who will be blinded {17a}
Participants in one cluster will not know about the interventions that are given to participants in other clusters. The usual care givers (doctor and the physiotherapist), and the physiotherapist who will be assessing the outcomes will be blinded to the intervention allocation.
Procedure for unblinding if needed {17b}
Not applicable
Data Collection And Management
Plans for assessment and collection of outcomes {18a}
The outcomes will be assessed using validated questionnaires and physical examinations (Table 3).
Table 3
Methods of measurement of outcomes.
Outcome Measure | Method of measurement |
Level of Pain | Numerical pain rating scale |
Physical disability | Oswestry neck disability questionnaire [23], Disability of shoulder arm and hand questionnaire (DASH) [24], Questionnaire to assess details of pain and demographic data, and clinical assessment of active and passive movement of neck and shoulder joint [5] |
Quality of Life | The SF-36 Questionnaire Short Form [25] |
Feelings on pain, physical disability and psycho social disability | Focus groups |
A questionnaire to assess details of presenting complaint, demographic data and details of medical and surgical history will be administered by the lead researcher. Physical and social disabilities will be assessed by a trained physiotherapist using methods listed in Table 3. Participants’ perceptions of the effects of meditation on pain, physical disability and psycho-social disability will be assessed using focus groups conducted by the lead researcher. The focus groups will be audio-recorded and transcribed verbatim. The transcriptions in Sinhala will then be translated into English.
Data collection forms can be obtained on request from the lead researcher.
The neck disability questionnaire consists of 10 sections which include questions on pain intensity, personal care (washing, dressing etc.,), lifting objects, reading, headaches, concentration, work, driving, sleeping and recreation. Under each section there are five responses graded from 0–5, whereby zero indicates no disability and five indicates the highest disability [23].
DASH consists of three sections which include questions on activities performed at home, work and during recreation. First section has thirty questions. Under each question there are five responses graded from 0–5, where zero indicates no difficulty and five indicates extreme difficulty [24].
The SF 36 questionnaire has 11 sections which include questions on vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. Under each section the potential responses range from 1–6 with higher scores indicating less disability [25].
Plans to promote participant retention and complete follow-up {18b}
Participants in the intervention groups will be taught meditation by an experienced meditation instructor during the first eight weeks on a weekly basis. At the beginning of the study, participants will be educated on the nature and potential purpose of meditation and, that for any potential benefits of meditation to be realised it is important that they practice their meditation on a regular basis for the required period of time. This intervention does not include any harmful or painful procedures, thus adverse events are unlikely. Participants will be regularly monitored on a weekly basis and if by any chance an adverse event does occur they will be referred to the appropriate specialist.
Data management {19} and Confidentiality {27}
Participants will be allocated a unique identification number at the beginning of the study. Participants will not be photographed or video-taped, but they will be audio recorded for focus groups. All identifiable data (names, addresses, contact details) and the main data will be encrypted and stored separately from each other in a secure folder that can only be accessed by the research team. A locked filing cabinet will be used to store non-digital data. The keys will be accessible only by the research team. Data will be protected for ten years. The results published from this study will be in the form of data for the whole group. During the study, monthly checks will be conducted by the research team comparing the hard and soft copies to identify any missing data.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Not applicable
Statistical Methods
Statistical methods for primary and secondary outcomes {20a}
If data is normally distributed, a two-way ANOVA will be used to explore any changes in the primary outcome between the intervention and usual care control groups and between groups at 8-week follow-up. Similarly, any changes in secondary outcomes between intervention and control groups and between groups will be explored at 4 and 12-week follow-up. If the data is not normally distributed, a nonparametric equivalent such as Kruskal Wallis will be used.
Multivariate linear regression will be used to explore any effect of the independent variables of age, gender, level of income, level of education, changes in the amount of medication used and the weekly, mean meditation duration on the primary outcome at 8-week follow-up and in the secondary outcomes at 4- and 12-week follow-up.
All focus groups will be audio-recorded and transcribed verbatim, and, translated to English [26]. For the qualitative data analysis, the literature recommends a scientific model be used [26]. To do this, the Richie and Spencer model will be used as it provides a sound analytical model [26]. Atlas ti will be used to manage the analysis for its usefulness in coding.
Interim analyses {21b}
Not applicable
Methods for additional analyses (e.g. subgroup analyses) {20b}
Not applicable
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
In calculating the sample size, adjustments were made to include for protocol non adherence.
Plans to give access to the full protocol, participant level-data and statistical code {31c}
When the trial results are published, an anonymised version of the dataset will also be provided as a supplementary file. Confidential data related to the trial participants will not be provided.
Oversight And Monitoring
Composition of the coordinating centre and trial steering committee {5d}
The trial will be handled by the three researchers who will meet once every two weeks to assess how the trial is running. In addition, there will be a physician and physiotherapist involved in the routine treatment of patients. The meditating instructor will train the participants in the meditation techniques, while another therapist will assess the outcomes. Allocating patients to usual care control and intervention arms and registering patients will be carried out by a nursing assistant. Data entry will be conducted by a research assistant.
Composition of the data monitoring committee, its role and reporting structure {21a}
Data monitoring will be conducted by the three researchers on a monthly basis.
Adverse event reporting and harms {22}
The interventions does not include any harmful procedures. Therefore, adverse events are unlikely.
Frequency and plans for auditing trial conduct {23}
Not applicable
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
At present we do not feel any protocol amendments are required. However, if any important protocol amendments are done, it will be notified to the University of Bath ethics committee, ISRCTN trial registry and the participants.
Dissemination plans {31a}
We intend to publish the trial results in scientific journals and present these at scientific conferences. There are no publication restrictions.