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Exploring the Effectiveness of Shortwave Diathermy in Patients with Chronic Low Back Pain

Effectiveness of Shortwave Diathermy in Patients with Chronic Low Back Pain: A Randomized Single-Blinded Multicenter Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097194
Enrollment
208
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M472- Other spondylosis with radiculopathy Health Condition 2: M190- Primary osteoarthritis of other joints

Interventions

Intervention1: Short Wave Diathermy: - Pulsed SWD (27.12 MHz, 100–150 W, 20 min per session, 3 session per week for 4 weeks) using Webstar-500 SWD machine. - Combined with standard physiotherapy (str

Sponsors

Mohammad Ali
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. A primary complaint of either: a. low back pain, defined as pain between the inferior costal margin and the inferior gluteal fold with or without referral into the leg(s) or b. referred leg pain without back pain, defined as predominately unilateral posterior leg pain extending below the knee, or anterior thigh pain, presumed to be of lumbar spine origin. 2. Duration of the current episode of primary complaint lasting for greater than 3 months (chronic stage of the injury) 3. Aged between 18 and 65 (inclusive) 4. Fluency in Bangla or English sufficient to complete questionnaires and to enable understanding of the intervention 5. Agreeing to refrain from other interventions wherever possible for the 10-week treatment period of the trial, aside from consultations with medical practitioners, medication, and any exercises already being undertaken

Exclusion criteria

Exclusion criteria: 1. Active cancer under current treatment, as the treatment of cancer may interfere with their ability to participate in the trial 2. Signs of cauda equina syndrome based on bladder or bowel disturbance and/or imaging 3. Current pregnancy, or childbirth within the last 6 months, as this could impair the ability to undertake exercises, and could also cause back and leg symptoms that are not related to the subgroups under investigation 4. Spinal injections within the last 6 weeks, as we wish to study treatment effects independent of the effects of injections 5. Any history of lumbar spine surgery, as there is already considerable research evaluating the efficacy of post-surgical rehabilitation programs 6. A pain intensity score of less than 2/10 on a 0-10 numerical rating scale due to low severity 7. Minimal activity limitation, evidenced by a baseline ability to walk, sit, and stand for one hour or more and no sleep disturbance at night, as we wish to exclude people with low severity 8. Already received more than 5 sessions of physiotherapy with any of the treating physiotherapists before enrolment, as this could influence treatment expectations in patients 9. Inability to walk safely, such as severe foot drop causing regular tripping, as the interventions in the trial include walking for most participants 10. Planned absence of more than one week during the treatment period (such as extended holidays)

Design outcomes

Primary

MeasureTime frame
1. Back pain intensity (0-10 numerical rating scale) 2. Leg pain intensity (0-10 numerical rating scale) 3. Activity limitation: Oswestry Disability Index V2.1 with sex life question replaced by a work or housework questionTimepoint: Baseline, 4 weeks, 12 weeks and 24 weeks.

Secondary

MeasureTime frame
1. Brief Pain Inventory: pain severity and pain interference 2. Global rating of change scale (7-point Likert scale) 3. Satisfaction with treatment (5-point Likert scale) 4. Interference with work or housework in the past week (5-point Likert scale), and number of work hours missed in the last 7 days 5. Orebro ¨ Musculoskeletal Pain Screening Questionnaire Short Form (¨OMPSQ-SF) 6. Quality of life (EuroQol-5D-5L) 7. Depression Anxiety and Stress Scale (DASS- 21) 8. Pain Self-Efficacy questionnaire (PSEQ) 9. Pain Catastrophizing Scale (PCS) 10. Insomnia Severity Index (ISI) 11. Central Sensitisation Inventory 9 (CSI-9) 12. Clinical inflammation score 13. Treatment Credibility Questionnaire 14. Healthcare utilisation (participant diary tracking health service utilisation, imaging, medication)Timepoint: Baseline, 4 weeks, 12 weeks and 24 weeks.

Countries

Bangladesh

Contacts

Public ContactMohammad Ali

Uttara Adhunik Medical College and Hospital

drmali2008@gmail.com01715043533

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026