Utility of neuromodulation, mindfulness and person-centered therapy in chronic low back pain
| ISRCTN | ISRCTN91142724 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91142724 |
| Secondary identifying numbers | SRHU/Ph.D.Cell/Sup/2023-14 |
- Submission date
- 21/09/2025
- Registration date
- 25/09/2025
- Last edited
- 24/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Low back pain (LBP) is a widespread public health issue with significant socioeconomic implications globally, affecting individuals across all age groups. Non-specific chronic low back pain (NSCLBP) is diagnosed after ruling out serious spinal pathology or nerve root involvement using clinical red flags and imaging such as X-rays or MRI scans. NSCLBP is among the leading causes of physician visits and disability, often resulting in missed work and reduced physical function, particularly in individuals under 45 years of age. This study aims to compare the effects of transcranial direct current stimulation (tDCS), mindfulness-based stress reduction therapy (MBSR), and cognitive functional therapy (CFT) as adjuvant therapy with standard medical treatment in patients with NSCLBP.
Who can participate?
Patients aged 20 to 55 years with NSCLBP
What does the study involve?
Participants were randomly allocated to one of four groups:
Group 1: standard medical treatment (pharmacological) (pain modification treatment)
Group 2: standard medical treatment and tDCS for 20 min 5 days per week for 2 consecutive weeks
Group 3: standard medical treatment and group therapy was given to the participants in two groups (15 participants in each group). Duration of each session was between 90-120 minutes. Sessions were given weekly. A total of 8-10 sessions was given.
Group 4: standard medical treatment and individually tailored CFT sessions were given to the patients. Sessions ranged from 8-12 sessions over a period of 12 weeks.
What are the possible benefits and risks of participating?
The potential benefits include reduction in pain and disability and improved overall wellbeing of the participants. Risks associated with the study are potential adverse effects of medication and tDCS.
Where is the study run from?
Swami Rama Himalayan University (India)
When is the study starting and how long is it expected to run for?
February 2022 to March 2025
Who is funding the study?
Swami Rama Himalayan University (India)
Who is the main contact?
Vithika Singh, ptvithikasingh@gmail.com
Contact information
Public, Scientific, Principal investigator
Research Cell, Department of Brain and Mind Sciences
Swami Rama Himalayan University
Dehradun
248016
India
| Phone | +91 (0)9540246442 |
|---|---|
| ptvithikasingh@gmail.com |
Study information
| Study design | Single-centre interventional open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, University/medical school/dental school |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Effects of transcranial direct current stimulation, mindfulness based stress reduction therapy, and cognitive functional therapy on pain intensity and disability in patients with non-specific chronic low back pain |
| Study objectives | Hypotheses: 1. Transcranial direct current stimulation (tDCS) will be useful as an adjunctive treatment for non-specific chronic low back pain (NSCLBP). 2. Mindfulness-based stress reduction therapy (MBSR) will be useful as an adjunctive treatment for NSCLBP. 3. Cognitive functional therapy (CFT) will be useful as an adjunctive treatment for NSCLBP. 4. There is no difference in efficacy of tDCS, MBSR and CFT in treatment of NSCLBP. |
| Ethics approval(s) |
Approved 27/01/2023, Ethics Committee (Swami Rama Nagar, P.O. Jolly Grant, Dehra Dun, 248016, India; +91 (0)135 2471111; research@srhu.edu.in), ref: SRHU/HIMS/ETHICS/2023/30 |
| Health condition(s) or problem(s) studied | Non-specific chronic low back pain |
| Intervention | Participants were randomly allocated to either of the four groups using a computer generated random number sequence: Group 1: standard medical treatment (pharmacological) (pain modification treatment) Group 2: standard medical treatment and received 2 mA of direct current was delivered for 20 min via sponge electrodes 5 days per week for 2 consecutive weeks. The active electrode (anode) was placed over the primary motor cortex using the International 10–20 system contralateral to the side of the worst low back pain (LBP). The reference electrode (cathode) was positioned over the contralateral supraorbital region ipsilateral to the side of pain. Group 3: standard medical treatment and group therapy was given to the participants in two groups (15 participants in each group). Duration of each session was between 90-120 minutes. Sessions were given weekly. A total of 8-10 sessions was given. Group 4: standard medical treatment and individually tailored CFT sessions were given to the patients. Sessions ranged from 8-12 sessions over a period of 12 weeks. |
| Intervention type | Mixed |
| Primary outcome measure | 1. Pain intensity measured using numeric rating scale at baseline (day 0), 3 months and 6 months 2. Disability measured using the Oswestry Disability Index at baseline (day 0), 3 months and 6 months |
| Secondary outcome measures | 1. Quality of life measured using RAND Sf36 questionnaire at baseline (day 0), 3 months and 6 months 2. Mindfulness assessed using Chronic Pain Acceptance Questionnaire, Mindfulness Awareness and Acceptance Questionnaire and Difficulty in Emotion Regulation scale within group 3 at baseline (day 0) and at 3 and 6 months from baseline |
| Overall study start date | 16/02/2022 |
| Completion date | 30/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 55 Years |
| Sex | All |
| Target number of participants | 160 |
| Total final enrolment | 134 |
| Key inclusion criteria | 1. Patients with NSCLBP 2. Aged between 20 and 55 years 3. Normal or minimal or non-specific changes on x-ray/MRI of lumbosacral spine 4. In case of multiple site pain, patient having low back pain as the most prominent presenting symptom 5. Patient who gives written informed consent |
| Key exclusion criteria | 1. Altered sensory or motor functions 2. Subjects with major painful comorbid medical conditions e.g., diabetic neuropathy, cancer, disc degeneration or prolapse, chronic kidney disease, chronic liver disease and other orthopaedic, rheumatological and painful neurological conditions 3. Any spine surgery in the preceding 6 months 4. Increased erythrocyte sedimentation rate (>30 mm/h) 5. Bone mineral density having t-score <-2.5 6. Specific psychiatric condition 7. Significant structural abnormality on imaging |
| Date of first enrolment | 31/01/2023 |
| Date of final enrolment | 30/09/2024 |
Locations
Countries of recruitment
- India
Study participating centre
Dehardun
248016
India
Sponsor information
University/education
Swami Rama Nagar, Jolly Grant
Dehradun
248016
India
| Phone | +91 (0)135 2471111 |
|---|---|
| research@srhu.edu.in | |
| Website | http://www.srhu.edu.in |
"ROR" |
https://ror.org/02nw97x94 |
Funders
Funder type
University/education
Private sector organisation / Universities (academic only)
- Alternative name(s)
- SRHU
- Location
- India
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Plans to publish in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Vithika Singh (ptvithikasingh@gmail.com) |
Editorial Notes
24/09/2025: Study's existence confirmed by Swami Rama Himalayan University.
