Investigator(s)
| Submitter |
Pema Wangda Ministry of Health Pema Wangda 
|
| Principal Investigator |
Pema Wangda Ministry of Health Pema Wangda
|
| Co-Investigator(s) |
Sangay Thinley ERRH, Mongar, Ministry of Health Sangay Thinley
|
| Co-Investigator(s) |
Sigay Dorji Wangdicholing Hospital, Bumthang, Ministry of Health Sigay Dorji
|
| Co-Investigator(s) |
Kuenzang Chophel Central Regional Referral Hospital, Gelephu, Sarpang, Ministry of Health Kuenzang Chophel
|
| Co-Investigator(s) |
Kinzang Kinzang National Traditional Medicine Hospital, Thimphu, Ministry of Health Kinzang Kinzang
|
| Co-Investigator(s) |
Tshokey Tshokey Trongsa Hospital, Trongsa, Ministry of Health Tshokey Tshokey
|
| Co-Investigator(s) |
Deki Lhamo Tsirang Hospital, Tsirang, Ministry of Health Deki Lhamo
|
| Co-Investigator(s) |
Milan Subbha Tsirang Hospital, Tsirang, Ministry of Health Milan Subbha
|
| Co-Investigator(s) |
Kinzang Dorji Haa Hospital, Haa, Ministry of Health Kinzang Dorji
|
| Co-Investigator(s) |
Rinzin Dorjee Haa Hospital, Haa, Ministry of Health Rinzin Dorjee
|
| Co-Investigator(s) |
Sangay Yuden Rangjung Hospital, Trashigang, Ministry of Health Sangay Yuden
|
| Co-Investigator(s) |
Thinley Gyelsthen Eastern Regional Referral Hospital, Mongar, Ministry of Health Thinley Gyelsthen
|
| Co-Investigator(s) |
Kinga Dendup Wangdicholing Hospital, Bumthang, Ministry of Health Kinga Dendup
|
| Co-Investigator(s) |
Tenzin Norzin Rangjung Hospital, Trashigang, Ministry of Health Tenzin Norzin
|
| Co-Investigator(s) |
Monu Tamang Central Regional Referral Hospital, Gelephu, Ministry of Health Monu Tamang
|
Title(s) and abstract
| Scientific title | Effect of rLangdugs Therapy in Pain Management of Acute Non-Specific Low Back Pain: A Multicenter Prospective Single Cohort Study in Bhutan |
| Public title | Effect of rLangDugs therapy in pain management of acute nonspecific low back pain in Bhutan. |
| Background | Low back pain is a widespread health issue, affecting 50-80% of adults globally, of which 90% of the cases account for NSLBP. In Bhutan musculoskeletal disorders ranked fourth in overall annual morbidity report with more than 92,000 cases reported in 2023. LBP is one of the most common conditions that people seek treatment across various traditional medicine (TM) clinics in Bhutan. In 2023 and 2024, Tsa-Kar has been reported as the most common disease presented in TM clinics across the country, of which LBP constitutes one of the most common conditions reported under this TM morbidity category. Amongst various management strategies of LBP, the current emphasis across the globe is on non-pharmacological, non-invasive and multidisciplinary interventions. This is where Bhutanese Traditional Medicine (BTM) plays a major role. In BTM, localized herbal steam therapy, known as rLang-dugs therapy is one of the most common non-pharmacological interventions availed by people for musculoskeletal conditions, such as LBP, in Bhutan. It is provided in all 83 TM facilities across Bhutan and it has been consistently among one of the most availed therapies along with acupuncture in the past five years (i.e. 2020-2024), with more than 30,000 patients availing the therapy in 2024. However, despite its long clinical history and ever widespread use in clinical settings across the country, there is no single scientific study that evaluated its effectiveness and safety in conditions that it’s indicated for. Further, since conventional pharmacological management of LBP is associated with several adverse side effects, the need to explore safe, effective and feasible alternatives has become ever more important. |
| Objectives | Primary objective: To evaluate the effect of LDT in relieving pain and improving functional mobility among patients with acute non-specific low back pain. Secondary Objectives: To study the effect of LDT in improving the quality of life of patients with acute NSLBP; and To study the safety of LDT as a non-pharmacological treatment regimen for acute non-specific low back pain. Null Hypothesis (H0): There is no significant improvement in pain reduction and functional mobility among acute NSLBP patients receiving LDT. Alternative Hypothesis (H1): LDT is associated with significant improvement in pain reduction and functional mobility among acute NSLBP patients. |
| Study Methods | Study design: This is a multi-center prospective single cohort study. Study Setting: This study will be conducted in outpatient clinics of traditional medicine in seven healthcare centers, which is representative of geographical diversity. These include National Traditional Medicine Hospital, Thimphu; Eastern Regional Referral hospital (ERRH) in Mongar, Central Regional Referral Hospital (CRRH) in Gelephu, Wangdi Chholing General Hospital in Bumthang, Tsirang Hospital in Tsirang, Haa hospital in Haa, and Rangjung hospital in Trashigang. Study Duration: The study will be conducted from August 2026 to January 2028 for a duration of 18 months. Sample Size: A total sample size of 341 participants will be recruited into the study. Participant Recruitment: Those patients who visit the above selected health centers will be screened for eligibility to participate in the study every Monday and Tuesday during clinic hours (between 9 am to 3 pm). Public announcement regarding the conduct of the study will be made through study site’s social media channels similar notice shall be made to surrounding communities and organizations Study exposure or treatment: Study participants will be exposed to localized herbal steam therapy, known as Standard rLangDugs therapy (SLT) for consecutive five sessions. Data Collection: Data collection pertaining to outcome assessments will be done at four different time points: before the intervention begins (Day 0), at the end of intervention (Day 5), on one month follow-up post-intervention, and on three month follow-up post intervention. |
| Expected outcomes and use of results | Primary outcomes: Reduction in pain intensity and improvement in functional mobility at the end of intervention period will be primary outcomes of this study. Pain intensity will be assessed using Facial Pain Scale-Revised (FPS-R) version. Disability or functional mobility will be assessed using Patient Specific Functional Scale (PSFS). Secondary Outcomes: Quality of life and safety of the SDT are the secondary outcomes of this study. Quality of life will be assessed using SF-12 Questionnaire, a 12 items self-administered questionnaire developed to assess quality of life. Patient safety of LDT will be assessed using adverse event report form, where every incidence of adverse event will be recorded and reported. Significance of the study: Findings of this study will determine how effective SLT is in treating musculo-skeletal conditions such as acute LBP. The results will also support evidence-informed clinical practice, healthcare planning, and policy decisions. |
| Keywords | Alternative Medicine; Complementary Therapies; Low Back Pain; Physical Therapy Modalities; Steam Bath; Traditional Medicine |
Research Details
| Student research | No |
| Start Date | 01-Aug-2026 |
| End Date | 31-Jan-2028 |
| Key Implementing Institution | Ministry of Health |
| Multi-country research | No |
| Nationwide research | No |
| Bhutan, Bhutan, Bhutan, Bhutan, Bhutan, Bhutan, Bhutan | |
| Research Domain(s) | Non-communicable diseases & Healthy Lifestyles |
| Research field(s) | Health Care Seeking/Utilization |
| Involves human subjects | Yes |
| Intervention Evaluation Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | No |