Low Back PainPhase 4DryNATiMPNCT06791434
Assessing the Benefits of Dry Needling for Low Back Pain When Combined With Regular Treatment
A Phase 4 study testing Fixed Dose Combination "Etoshine MR" tablets, Dry needling and Physiotherapy in people with Low Back Pain, run by Dr. Vishwanath Karad MIT World Peace University at 1 site in India.
Trial summary
The proposed clinical study aims to evaluate the effectiveness and safety of adding Dry Needling (DN) to Conventional Treatment (CT) for patients with Myofascial Low Back Pain (MLBP). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Fixed Dose Combination "Etoshine MR" tablets, Dry needling and Physiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteIndia
- Study dates
- 30 Aug 2024to 26 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject diagnosed with myofascial low back pain, characterized by the presence of trigger points and localized muscle pain/tenderness
- Subject experiencing myofascial pain symptoms (e.g., muscle pain, tenderness) for at least 3 months
- Subject has a baseline Numeric Pain Rating Scale (NPRS) score of 4 or higher
- Subject has stable medical condition that is not expected to significantly deteriorate during the study period in the opinion of the investigator
- Woman who is postmenopausal for 12 months or less before screening (unless permanently sterilized or using an IUD) must have a negative urine pregnancy test prior to the randomization visit
- Subject is willing to comply with all aspects of the study protocol, including attending scheduled appointments, completing study assessments and adhering to applicable restrictions
- Subject has provided informed consent to participate in the study
- No spine/lumbar surgery in the last 6 months
Who cannot join
- Subject presenting sharp, shooting pain radiating to lower limbs (associated with tingling and numbness) along with back pain
- Subject with active systemic or local infection(s)
- Subject with bleeding disorder(s) or on anticoagulant medication(s)
- Subject currently experiencing or with a history of psychiatric condition, cognitive impairment, neurological disorder, or other clinically significant disease or abnormality (such as congestive heart failure, uncontrolled hypertension, myocardial infarction, stroke, uncontrolled coronary artery disease, arrhythmias, uncontrolled diabetes, convulsive disorders etc.) which, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study, or would interfere with their ability to complete the study, or would hinder their ability to understand the study procedures, or would impact their compliance with study assessments or treatment protocols, or would affect pain perception
- Subject with a history of allergy or hypersensitivity to Etoricoxib, Thiocolchicoside or Diclofenac
- Subject with a history of alcohol or substance abuse
- Woman who is pregnant or planning pregnancy during the course of the study
- Subject who is currently participating in or has participated in any other clinical trial within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Dry Needling as an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: A Randomized Controlled Trial
The proposed clinical study aims to evaluate the effectiveness and safety of adding Dry Needling (DN) to Conventional Treatment (CT) for patients with Myofascial Low Back Pain (MLBP). MLBP is a widespread musculoskeletal condition that causes localized pain, muscle tenderness, and functional limitations, significantly affecting the quality of life and productivity of those affected. Conventional Treatment for MLBP typically combines pharmacotherapy (e.g., NSAIDs, muscle relaxants) and physiotherapy. Dry Needling, an emerging treatment that targets myofascial trigger points with fine needles, has demonstrated promise in relieving pain and improving functional outcomes. However, no study has yet evaluated the combined effects of CT and DN. This randomized, open-label, controlled trial will involve 140 patients (70 per group) and compare the effects of CT alone versus CT combined with DN. The primary objective is to assess the change in pain intensity, while secondary objectives include improvements in pressure pain threshold, range of motion, disability, quality of life, sleep, anxiety, and depression scores.
Safety will also be assessed based on adverse events and vital sign changes. The study will span 24 weeks, with 11 scheduled visits for each participant. Data analysis will be conducted to determine the added benefit of DN as an adjunctive therapy to CT, with the ultimate goal of improving treatment strategies and patient outcomes for MLBP.
- Conditions
- Low Back Pain
- Being tested
- Fixed Dose Combination "Etoshine MR" tablets, Dry needling, Physiotherapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed Dose Combination "Etoshine MR" tabletsDrug
Composition per tablet: Etoricoxib 60 mg + Thiocolchicoside 4 mg
Dry needlingProcedure or surgery
Thin needle insertion
PhysiotherapyOther
Exercises
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment (CT) Group | Active comparator | Also known as Control group. In this group, patients to follow prescribed pharmacotherapy (Fixed Dose Combination "Etoshine MR" tablets BID) daily for first 2 weeks and prescribed physiotherapy daily until Day 168. Receives: Drug: Fixed Dose Combination "Etoshine MR" tablets; Other: Physiotherapy |
| Conventional Treatment + Dry Needling (CT+DN) Group | Experimental | Also known as Add-on group. In this group, in addition to the treatment prescribed for the CT group, patients to also receive 5 dry needling sessions scheduled on Day 0, 3, 7, 10, and 14. Receives: Drug: Fixed Dose Combination "Etoshine MR" tablets; Procedure: Dry needling; Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NPRS) is a widely used, validated tool for assessing pain intensity. Patients are asked to rate their pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. This simple and reliable scale allows patients to quantify their pain level, aiding clinicians in monitoring pain over time and assessing the effectiveness of treatment interventions.
Measured: Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Secondary outcomes (7)
Change in Pressure Pain Threshold using Algometer
Pressure Pain Threshold (PPT) measurement using an algometer is a quantitative method employed to assess pain sensitivity in individuals with low back pain. During the assessment, pressure applied to the target area (perpendicular to the muscle) using the algometer probe is gradually increased until the sensation changes from pressure to pain. The pressure at which this transition occurs is recorded as the PPT. This objective measure helps evaluate pain sensitivity and tolerance levels in individuals with low back pain, providing valuable insights into the efficacy of treatment interventions.
Measured: Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Change in Range of Motion
Range of Motion (ROM) assessment is a fundamental component in musculoskeletal evaluation. It provides insights into joint mobility, flexibility, and functional limitations.
Specific ROM measurement included in this study is as follows:
Fingertip-to-Floor Distance (FTF) in Flexion: The patient bends forward, attempting to reach the floor with their fingertips. A standard measuring tape gauges the distance between the right long finger and the floor.
Measured: Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Change in Physical Disability using Salen's Disability Rating Index (DRI)
Disability Rating Index (DRI) is a patient-reported questionnaire that measures physical disability in patients. It was developed in 1994 by Salén et al. DRI questionnaire comprises of 12 items, each measured using a visual analogue scale [VAS (0-100)], where 0 indicates no disability and 100 an inability to perform any activity. The mean of the 12 items provides the overall DRI score. The items are broadly grouped into three distinct sections: (i) questions 1-4, basic activities of daily life: dressing, outdoor walks, climbing stairs, sitting a long time; (ii) questions 5-8, daily physical activities: standing bent over a sink, carrying a bag, making a bed, running; and (iii) questions 9-12, work-related/more vigorous activities: light work, heavy work, lifting heavy objects and participating in exercise/sports.
Measured: Day 0, 7, 14, 28, 56, 84, 168
Change in Pain and Sleep using Pain and Sleep Questionnaire (PSQ-3)
The Pain and Sleep Questionnaire (PSQ-3) is a concise tool designed to evaluate the influence of pain on sleep quality. Each of the 3 items is scored individually on a 100 mm Visual Analog Scale (VAS), ranging from 0 (representing 'never') to 100 (indicating 'always'). The total score is obtained by summing up the scores of all three items, providing a comprehensive measure of the impact of pain on sleep quality. By quantifying the frequency of sleep disturbances attributed to pain, the PSQ-3 provides valuable insights into the intricate relationship between pain and sleep, crucial for assessing the holistic impact of myofascial low back pain on patients' well-being.
Measured: Day 0, 7, 14, 28, 56, 84, 168
Change in Quality of Life Scale Score using Burckhardt's Quality of Life Scale (QOLS)
Burckhardt's Quality of Life Scale (QOLS) is a self-reported measure assessing overall quality of life across physical, psychological, and social domains. It comprises of 16 items related to life satisfaction, including health, relationships, and daily activities. Participants rate each item, providing insights into their perceived well-being. Each item is scored on a Likert-type scale ranging from 7 to 1, where 7 ="Delighted" to 1 = "Terrible". The QOLS offers a comprehensive assessment, valuable for evaluating the impact of health conditions like myofascial low back pain on quality of life. Total score is obtained by adding up the score on each item. Range of the total score: 16-112. Higher score indicates better quality of life.
Measured: Day 0, 7, 14, 28, 56, 84, 168
Change in Patients Impression using Patients' Global Impression of Change (PGI-C) Scale
Patients' Global Impression of Change (PGI-C) scale allows participants to subjectively assess their overall improvement or worsening of back pain symptoms since the start of the study. It consists of seven options ranging from "Very Much Improved" to "Very Much Worse." The PGI-C scale provides valuable insights into participants' perceptions of the effectiveness of the treatment.
Measured: Day 3, 7, 14, 28, 56, 84, 168
Change in Severity of Anxiety and Depression Symptoms using Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) is a widely used self-assessment tool designed to measure the severity of anxiety and depression symptoms in individuals with physical health conditions. It consists of 14 items, with seven items each assessing anxiety and depression separately. Respondents rate their feelings over the past week using the respective scores which range from 0 to 3. Higher the score out of 21, higher the severity of anxiety/depression. Monitoring the changes in anxiety and depression scores throughout the study can provide valuable data on the impact of treatment on patients' mental health.
Measured: Day 0, 7, 14, 28, 56, 84, 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start30 Aug 2024
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Vishwanath Karad MIT World Peace University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deshbandhu Pachauri, Dr. Vishwanath Karad MIT World Peace University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791434
- Sponsor's protocol ID
- MITWPU-CS-01
- Acronym
- DryNATiMP
- Status last verified
- Feb 2026
- First submitted
- 31 Dec 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.
PubMed 16945250Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
PubMed 20823359
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Dry Needling as an Add-on Therapy to Conventional Treatment for Myofascial Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06791434
- Acronym / sponsor ID
- DryNATiMP / MITWPU-CS-01
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Dr. Vishwanath Karad MIT World Peace UniversityUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed clinical study aims to evaluate the effectiveness and safety of adding Dry Needling (DN) to Conventional Treatment (CT) for patients with Myofascial Low Back Pain (MLBP). MLBP is a widespread musculoskeletal condition that causes localized pain, muscle tenderness, and functional limitations, significantly affecting the quality of life and productivity of those affected. Conventional Treatment for MLBP typically combines pharmacotherapy (e.g., NSAIDs, muscle relaxants) and physiotherapy. Dry Needling, an emerging treatment that targets myofascial trigger points with fine needles, has demonstrated promise in relieving pain and improving functional outcomes. However, no study has yet evaluated the combined effects of CT and DN. This randomized, open-label, controlled trial will involve 140 patients (70 per group) and compare the effects of CT alone versus CT combined with DN. The primary objective is to assess the change in pain intensity, while secondary objectives include improvements in pressure pain threshold, range of motion, disability, quality of life, sleep, anxiety, and depression scores.
Safety will also be assessed based on adverse events and vital sign changes. The study will span 24 weeks, with 11 scheduled visits for each participant. Data analysis will be conducted to determine the added benefit of DN as an adjunctive therapy to CT, with the ultimate goal of improving treatment strategies and patient outcomes for MLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment (CT) Group | Active comparator | Drug: Fixed Dose Combination "Etoshine MR" tablets, Other: PhysiotherapyAlso known as Control group. In this group, patients to follow prescribed pharmacotherapy (Fixed Dose Combination "Etoshine MR" tablets BID) daily for first 2 weeks and prescribed physiotherapy daily until Day 168. |
| Conventional Treatment + Dry Needling (CT+DN) Group | Experimental | Drug: Fixed Dose Combination "Etoshine MR" tablets, Procedure: Dry needling, Other: PhysiotherapyAlso known as Add-on group. In this group, in addition to the treatment prescribed for the CT group, patients to also receive 5 dry needling sessions scheduled on Day 0, 3, 7, 10, and 14. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject diagnosed with myofascial low back pain, characterized by the presence of trigger points and localized muscle pain/tenderness
- Subject experiencing myofascial pain symptoms (e.g., muscle pain, tenderness) for at least 3 months
- Subject has a baseline Numeric Pain Rating Scale (NPRS) score of 4 or higher
- Subject has stable medical condition that is not expected to significantly deteriorate during the study period in the opinion of the investigator
- Woman who is postmenopausal for 12 months or less before screening (unless permanently sterilized or using an IUD) must have a negative urine pregnancy test prior to the randomization visit
Key exclusion criteria (8 listed)
- Subject presenting sharp, shooting pain radiating to lower limbs (associated with tingling and numbness) along with back pain
- Subject with active systemic or local infection(s)
- Subject with bleeding disorder(s) or on anticoagulant medication(s)
- Subject currently experiencing or with a history of psychiatric condition, cognitive impairment, neurological disorder, or other clinically significant disease or abnormality (such as congestive heart failure, uncontrolled hypertension, myocardial infarction, stroke, uncontrolled coronary artery disease, arrhythmias, uncontrolled diabetes, convulsive disorders etc.) which, in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study, or would interfere with their ability to complete the study, or would hinder their ability to understand the study procedures, or would impact their compliance with study assessments or treatment protocols, or would affect pain perception
- Subject with a history of allergy or hypersensitivity to Etoricoxib, Thiocolchicoside or Diclofenac
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed Dose Combination "Etoshine MR" tabletsComposition per tablet: Etoricoxib 60 mg + Thiocolchicoside 4 mg | Drug | Conventional Treatment (CT) Group, Conventional Treatment + Dry Needling (CT+DN) Group |
| Dry needlingThin needle insertion | Procedure or surgery | Conventional Treatment + Dry Needling (CT+DN) Group |
| PhysiotherapyExercises | Other | Conventional Treatment (CT) Group, Conventional Treatment + Dry Needling (CT+DN) Group |
Primary outcome
Change in Pain Intensity using Numeric Pain Rating Scale (NPRS)
Time frame: Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Numeric Pain Rating Scale (NPRS) is a widely used, validated tool for assessing pain intensity. Patients are asked to rate their pain on a scale from 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. This simple and reliable scale allows patients to quantify their pain level, aiding clinicians in monitoring pain over time and assessing the effectiveness of treatment interventions.
7 secondary outcomes
Change in Pressure Pain Threshold using Algometer
Time frame: Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Change in Range of Motion
Time frame: Day 0, 3, 7, 10, 14, 28, 56, 84, 168
Change in Physical Disability using Salen's Disability Rating Index (DRI)
Time frame: Day 0, 7, 14, 28, 56, 84, 168
Change in Pain and Sleep using Pain and Sleep Questionnaire (PSQ-3)
Time frame: Day 0, 7, 14, 28, 56, 84, 168
Change in Quality of Life Scale Score using Burckhardt's Quality of Life Scale (QOLS)
Time frame: Day 0, 7, 14, 28, 56, 84, 168
Change in Patients Impression using Patients' Global Impression of Change (PGI-C) Scale
Time frame: Day 3, 7, 14, 28, 56, 84, 168
Change in Severity of Anxiety and Depression Symptoms using Hospital Anxiety and Depression Scale (HADS)
Time frame: Day 0, 7, 14, 28, 56, 84, 168
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Background: PubMed 16945250Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.
- Background: PubMed 20823359Kalichman L, Vulfsons S. Dry needling in the management of musculoskeletal pain. J Am Board Fam Med. 2010 Sep-Oct;23(5):640-6. doi: 10.3122/jabfm.2010.05.090296.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fixed Dose Combination "Etoshine MR" tablets, Dry needling and Physiotherapy in people with Low Back Pain, run by Dr. Vishwanath Karad MIT World Peace University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity using Numeric Pain Rating Scale (NPRS) (time frame: Screening, Day 0, 3, 7, 10, 14, 28, 56, 84, 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06791434, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.