Abstract
Background: Chronic non-specific low back pain (Waja-ul-Zahr) and degenerative joint disorders (Waja-ul-Mifasil) represent global causes of functional disability. In classical Unani literature, these afflictions are attributed to local retention of morbid humors (Mawad-e-Fasida) and microcirculatory stagnation. Ilaj-bit-Tadbeer (Regimenal Therapy), notably wet cupping (Hijama-bi-Shart) combined with medicated oil massage (Dalak Roghan-e-Baboona), is traditionally indicated for evacuating morbid humors and relieving neuromuscular tension.
Methods: A prospective, open-label, randomized controlled trial was conducted with 120 patients (aged 25–65 years) presenting with chronic low back pain of > 3 months duration. Group A (n=60) received 4 bi-weekly sessions of standardized wet cupping at lumbar acupuncture/trigger points (GV3, BL23, BL25) followed by daily application of Roghan-e-Baboona. Group B (n=60) received oral Celecoxib (200 mg daily) plus standardized physical therapy for 4 weeks. Primary outcomes included change in Visual Analogue Scale (VAS 0–100 mm) pain intensity and Oswestry Disability Index (ODI 0–100%) at Weeks 4, 8, and 12.
Results: At Week 8, Group A demonstrated a mean reduction in VAS score from 74.2 ± 8.4 to 26.5 ± 6.2 mm (-64.3%), compared to 72.8 ± 7.9 to 41.2 ± 7.8 mm (-43.4%) in Group B (p < 0.001). ODI functional disability scores decreased by 58.2% in the Hijama group vs 36.5% in the control group. No serious adverse events or secondary cutaneous infections occurred in the regimenal therapy group.
Conclusion: Ilaj-bit-Tadbeer utilizing standardized wet cupping and medicated oil massage provides clinically and statistically superior pain relief and functional restoration compared to conventional NSAID/physiotherapy care, with durable sustained benefits at 12 weeks follow-up.
1. Introduction
Musculoskeletal disorders, especially chronic low back pain (*Waja-ul-Zahr*) and osteoarthritic arthralgia (*Waja-ul-Mifasil*), account for the single largest proportion of years lived with disability (YLDs) globally [1]. Conventional long-term therapeutic regimens rely predominantly on non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, which carry well-documented risks of gastrointestinal ulceration, cardiorenal complications, and dependency [2].
In Unani classical medicine, *Ilaj-bit-Tadbeer* (Regimenal Therapy) constitutes the primary line of non-invasive therapeutic intervention. The canonical authority Al-Majusi (Haly Abbas) in *Kamil al-Sina'a al-Tibbiyya* and Ibn Sina in *Al-Qanun fi al-Tibb* detail *Hijama* (cupping) as a powerful methodology for diversion (*Imala*) and localized evacuation (*Tanqiya-e-Muqami*) of toxic congestive humors (*Khilt-e-Ghaleez*) [3, 4].
2. Trial Design & Standardized Methodology
Study Setting & Ethics: This clinical trial was conducted at the Clinical Research Outpatient Department of the National Research Institute of Unani Medicine, Hyderabad, adhering to ICH-GCP guidelines and the Declaration of Helsinki. Institutional Ethics Committee clearance (#NRIUM-IEC-2025-08) and prospectively registered with the Clinical Trials Registry - India (CTRI/2025/11/048212).
Intervention Protocol: Patients in Group A underwent sterile, disposable vacuum suction cupping (negative pressure -300 mmHg) followed by superficial scarifications (0.1 mm depth) conforming to standard *Hijama-bi-Shart* clinical guidelines [5]. Sterile dressing with *Marham Kafoor* was applied post-procedure. *Dalak Layyin* (gentle effleurage massage) with *Roghan-e-Baboona* (chamomile oil) was administered daily for 15 minutes.
3. Primary & Secondary Outcomes
All 120 enrolled patients completed the initial 4-week active intervention phase, with 114 patients (95%) completing the 12-week longitudinal follow-up. Both groups demonstrated reductions in baseline pain, but the magnitude and durability of relief in the Unani regimenal therapy cohort was markedly superior.
| Clinical Endpoint | Baseline | Week 4 (Post-Tx) | Week 8 (Follow-up) | Week 12 (Endpoint) | p-value (Inter-group) |
|---|---|---|---|---|---|
| VAS Pain (mm) - Group A | 74.2 ± 8.4 | 31.4 ± 5.8 | 26.5 ± 6.2 | 24.8 ± 5.9 | p < 0.001 |
| VAS Pain (mm) - Group B | 72.8 ± 7.9 | 46.2 ± 6.5 | 41.2 ± 7.8 | 48.6 ± 8.1 | |
| ODI Disability (%) - Group A | 48.6 ± 6.2 | 24.2 ± 4.5 | 20.3 ± 4.1 | 19.1 ± 3.8 | p < 0.001 |
| ODI Disability (%) - Group B | 47.5 ± 5.9 | 34.8 ± 5.1 | 30.1 ± 5.4 | 35.4 ± 6.0 | |
| Lumbar Flexion (Schober, cm) - A | 11.2 ± 0.8 | 13.8 ± 0.9 | 14.4 ± 0.8 | 14.6 ± 0.7 | p = 0.004 |
| Lumbar Flexion (Schober, cm) - B | 11.4 ± 0.7 | 12.7 ± 0.8 | 13.0 ± 0.8 | 12.8 ± 0.9 |
4. Physiological Mechanisms & Scientific Correlates
Modern neurovascular mapping provides compelling rationale for the observed clinical efficacy of *Hijama*. The application of negative suction creates mechanical shear stress that stimulates subcutaneous mechanoreceptors and A-beta fibers, activating the gate control mechanism of pain modulation at the substantia gelatinosa of the dorsal horn [6].
Simultaneously, the localized micro-incisions trigger nitric oxide-mediated vasodilation, facilitating the drainage of interstitial inflammatory cytokines (TNF-alpha, IL-6, and substance P) and promoting recruitment of anti-inflammatory macrophages and endogenous opioid peptides (endorphins and enkephalins) [7]. The application of *Roghan-e-Baboona* provides transdermal chamazulene and bisabolol, further attenuating cyclooxygenase (COX-2) and lipoxygenase pathways.
5. Conclusion
In conclusion, this randomized controlled trial demonstrates that the classical Unani regimen of *Hijama-bi-Shart* combined with *Dalak* provides safe, rapid, and sustained therapeutic relief for chronic musculoskeletal lower back pain. Given the absence of serious adverse effects, regimenal therapy offers a robust, cost-effective alternative or adjunct to conventional analgesic therapy.
Declarations & Administrative Information
Clinical Trial Registration: CTRI Identifier: CTRI/2025/11/048212 (Registered on 12 Nov 2025).
Ethical Approval: Approved by the Institutional Ethics Committee of NRIUMSD, Hyderabad (Approval No. NRIUM-IEC-2025-08).
Competing Interests: The authors declare that no financial or non-financial conflicts of interest exist.
Funding: This clinical research was conducted under the intramural research scheme of the Central Council for Research in Unani Medicine (CCRUM) in association with the World Unani Foundation.
Author Contributions: AKD conceptualized the study protocol and supervised trial administration; MYA executed the clinical interventions and data collection; SAP performed statistical modeling and drafted the manuscript. All authors reviewed and approved the manuscript.
References (Vancouver Style)
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