SciaticaNCT02770963
Efficacy of Acupuncture for Discogenic Sciatica
A study testing Acupuncture in people with Sciatica, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sciatica
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jun 2018
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral leg pain diagnosed as discogenic sciatica;
- Sciatica patients with an average leg pain VAS of 40 mm or higher in the last 24 hours;
- Aged 18 to 75 years;
- Leg pains that correlate with CT or MRI findings of lumbar disc herniation;
- Patients who agree to follow the trial protocol.
Who cannot join
- Severe cases with central or giant or ruptured lumbar disc herniation, cauda equina syndrome, foot drop, or surgery requirements;
- Progressive neurological symptoms after 3 months of strict conservative treatment (e.g., nerve root adhesion, crossed straight-leg testing, or obvious muscle atrophy);
- Severe cardiovascular, liver, kidney, hematopoietic system diseases, autoimmune diseases, or poor nutritional status;
- Subjects with cognitive impairment;
- Pregnancy;
- Subjects who received acupuncture for sciatica within the past month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, 100053
Qin Yao, +86-15650728152, 1126873424@qq.com
Zhishun Liu, +86-10-88001124, liuzhishun@aliyun.com
About this study
Official title: Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial
This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.
Read the detailed description
Background: Sciatica is primarily caused by herniated discs with nerve-root compression. Acupuncture may effectively relieve the pain of discogenic sciatica, but the evidence is limited.
Methods/Design: Sixty patients with discogenic sciatica will be recruited and randomized to receive acupuncture or sham-acupuncture at a 1:1 ratio. Patients in both groups will receive treatment 3 times per week for 4 weeks. The following acupoints will be used: Dachang shu (BL 25), Shenshu (BL 23), Weizhong (BL 40), and Chengshan (BL 57).
- Conditions
- Sciatica
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- discogenic, Acupuncture Therapy, randomized controlled trial
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Shenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied.
A Huatuo Brand needle (0.3*75 mm) for BL25 will be inserted at a depth of 40-70 mm vertically until the patient feels soreness and a distension sensation that radiates to the leg. The needle will be lifted 1-2 mm without rotating or lifting. Huatuo Brand needles (0.3*40 mm) at the other acupoints (BL23, BL40 and BL57) will be inserted 30 mm and manipulated by lifting, thrusting, twirling evenly until the Deqi sensation is achieved. The needles in these acupoints will be manipulated by small evenly applied lifting, thrusting, and twirling movements 3 times every 10 minutes.
Sham acupunctureProcedure or surgery
Specially designed sham needles (0.3*25 mm) will be used. The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group).
The acupoints will be the same as the acupuncture group. The needle will be inserted vertically until pressed against the skin without penetration. The manipulation will be consistent with the acupuncture group and blind to the patients.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Shenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied.
Huatuo Brand needle (0.3*75 mm) will be used for BL25 and Huatuo Brand needle (0.3*40mm) will be used for BL23, BL40 and BL57. Receives: Procedure: Acupuncture |
| Sham acupuncture | Sham comparator | The acupoints will be the same as the acupuncture group. Specially designed sham needles (0.3*25 mm) will be used . The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group). Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in mean weekly VAS of leg pain
VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of leg pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of leg pain over weeks 1-4 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
Measured: Baseline, weeks 1-4, week 16 and week 28
Secondary outcomes (6)
Change in mean weekly VAS of low back pain
Patients will rate their average low back pain intensity in the past 24 hours using VAS. The mean weekly VAS of low back pain over weeks 1-4 will be calculated as described above for the mean weekly VAS of leg pain over weeks 1-4.
Measured: Baseline, weeks 1-4, week 16 and week 28
Oswestry disability index
ODI consists of 10 questions, including pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question is scored on a scale of 0-5. The scores for all questions answered are summed and divided by the highest possible score to obtain the index (range 0% to 100%). 0% equals no disability, and 100% is the maximum disability possible
Measured: Baseline, week 4, week 16 and week 28
Patients' global impressions of improvement
Patients' global impressions of improvement measured using a Likert 7-point scale (higher scores indicate worse outcome).
Measured: week 4
Patients' expectations for acupuncture
This questionnaire includes three brief questions to investigate whether patients believe that acupuncture treatment will help their sciatica. The relationship between patients' expectations and the effectiveness of acupuncture will be investigated because patients' beliefs about treatment enhanced or attenuated the effectiveness of treatment in a previous experimental study .
Measured: baseline
Blinded evaluation
Blinded evaluation as measured by patient questioning of whether they believed they received real acupuncture at week 4. The difference in the proportion of patients who believed that they received real acupuncture between the two groups will be analyzed.
Measured: week 4
Incidence of serious adverse events
The investigators will record and evaluate all adverse events .
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Yao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Qin Yao, Principal investigator, Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770963
- Sponsor's protocol ID
- 2016010401
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ. 2007 Jun 23;334(7607):1313-7. doi: 10.1136/bmj.39223.428495.BE. No abstract available.
PubMed 17585160Valat JP, Genevay S, Marty M, Rozenberg S, Koes B. Sciatica. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):241-52. doi: 10.1016/j.berh.2009.11.005.
PubMed 20227645Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015 Mar 26;372(13):1240-8. doi: 10.1056/NEJMra1410151. No abstract available.
PubMed 25806916Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available.
PubMed 22078311Asche CV, Kirkness CS, McAdam-Marx C, Fritz JM. The societal costs of low back pain: data published between 2001 and 2007. J Pain Palliat Care Pharmacother. 2007;21(4):25-33.
PubMed 18032313Thomas KC, Fisher CG, Boyd M, Bishop P, Wing P, Dvorak MF. Outcome evaluation of surgical and nonsurgical management of lumbar disc protrusion causing radiculopathy. Spine (Phila Pa 1976). 2007 Jun 1;32(13):1414-22. doi: 10.1097/BRS.0b013e318060a5d1.
PubMed 17545909Ji M, Wang X, Chen M, Shen Y, Zhang X, Yang J. The Efficacy of Acupuncture for the Treatment of Sciatica: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:192808. doi: 10.1155/2015/192808. Epub 2015 Sep 6.
PubMed 26425130Qin Z, Liu X, Wu J, Zhai Y, Liu Z. Effectiveness of Acupuncture for Treating Sciatica: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:425108. doi: 10.1155/2015/425108. Epub 2015 Oct 21.
PubMed 26576192Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.
PubMed 24239490MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. J Altern Complement Med. 2010 Oct;16(10):ST1-14. doi: 10.1089/acm.2010.1610.
PubMed 20954957Liu B, Xu H, Ma R, Mo Q, Yan S, Liu Z. Effect of blinding with a new pragmatic placebo needle: a randomized controlled crossover study. Medicine (Baltimore). 2014 Dec;93(27):e200. doi: 10.1097/MD.0000000000000200.
PubMed 25501074Porchet F, Wietlisbach V, Burnand B, Daeppen K, Villemure JG, Vader JP. Relationship between severity of lumbar disc disease and disability scores in sciatica patients. Neurosurgery. 2002 Jun;50(6):1253-9; discussion 1259-60. doi: 10.1097/00006123-200206000-00014.
PubMed 12015843Cohen SP, Bogduk N, Dragovich A, Buckenmaier CC 3rd, Griffith S, Kurihara C, Raymond J, Richter PJ, Williams N, Yaksh TL. Randomized, double-blind, placebo-controlled, dose-response, and preclinical safety study of transforaminal epidural etanercept for the treatment of sciatica. Anesthesiology. 2009 May;110(5):1116-26. doi: 10.1097/ALN.0b013e3181a05aa0.
PubMed 19387178Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
PubMed 11074683Sherman KJ, Cherkin DC, Ichikawa L, Avins AL, Delaney K, Barlow WE, Khalsa PS, Deyo RA. Treatment expectations and preferences as predictors of outcome of acupuncture for chronic back pain. Spine (Phila Pa 1976). 2010 Jul 1;35(15):1471-7. doi: 10.1097/BRS.0b013e3181c2a8d3.
PubMed 20535051
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture for Discogenic Sciatica: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02770963
- Acronym / sponsor ID
- 2016010401
- Conditions
- Sciatica
- Keywords
- discogenic, Acupuncture Therapy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 12 May 2016 (estimated)
- 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.
This trial is designed to evaluate the efficacy of acupuncture on pain relief for patients with discogenic sciatica compared with sham acupuncture.
Detailed description
Background: Sciatica is primarily caused by herniated discs with nerve-root compression. Acupuncture may effectively relieve the pain of discogenic sciatica, but the evidence is limited.
Methods/Design: Sixty patients with discogenic sciatica will be recruited and randomized to receive acupuncture or sham-acupuncture at a 1:1 ratio. Patients in both groups will receive treatment 3 times per week for 4 weeks. The following acupoints will be used: Dachang shu (BL 25), Shenshu (BL 23), Weizhong (BL 40), and Chengshan (BL 57).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureShenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied. Huatuo Brand needle (0.3*75 mm) will be used for BL25 and Huatuo Brand needle (0.3*40mm) will be used for BL23, BL40 and BL57. |
| Sham acupuncture | Sham comparator | Procedure: Sham acupunctureThe acupoints will be the same as the acupuncture group. Specially designed sham needles (0.3*25 mm) will be used . The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral leg pain diagnosed as discogenic sciatica;
- Sciatica patients with an average leg pain VAS of 40 mm or higher in the last 24 hours;
- Aged 18 to 75 years;
- Leg pains that correlate with CT or MRI findings of lumbar disc herniation;
- Patients who agree to follow the trial protocol.
Key exclusion criteria (6 listed)
- Severe cases with central or giant or ruptured lumbar disc herniation, cauda equina syndrome, foot drop, or surgery requirements;
- Progressive neurological symptoms after 3 months of strict conservative treatment (e.g., nerve root adhesion, crossed straight-leg testing, or obvious muscle atrophy);
- Severe cardiovascular, liver, kidney, hematopoietic system diseases, autoimmune diseases, or poor nutritional status;
- Subjects with cognitive impairment;
- Pregnancy;
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 |
|---|---|---|
| AcupunctureShenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied. A Huatuo Brand needle (0.3*75 mm) for BL25 will be inserted at a depth of 40-70 mm vertically until the patient feels soreness and a distension sensation that radiates to the leg. The needle will be lifted 1-2 mm without rotating or lifting. Huatuo Brand needles (0.3*40 mm) at the other acupoints (BL23, BL40 and BL57) will be inserted 30 mm and manipulated by lifting, thrusting, twirling evenly until the Deqi sensation is achieved. The needles in these acupoints will be manipulated by small evenly applied lifting, thrusting, and twirling movements 3 times every 10 minutes. | Procedure or surgery | Acupuncture |
| Sham acupunctureSpecially designed sham needles (0.3*25 mm) will be used. The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group). The acupoints will be the same as the acupuncture group. The needle will be inserted vertically until pressed against the skin without penetration. The manipulation will be consistent with the acupuncture group and blind to the patients. | Procedure or surgery | Sham acupuncture |
Primary outcome
change from baseline in mean weekly VAS of leg pain
Time frame: Baseline, weeks 1-4, week 16 and week 28
VAS uses a 100-mm line that is labeled at each end, and 0 mm represents no pain, and 100 mm represents unbearable pain. Patients will rate the VAS (average VAS of leg pain in the past 24 hours), and a researcher will record the VAS once weekly, generally at the third weekly treatment. The mean weekly VAS of leg pain over weeks 1-4 will be calculated as the sum VAS of each week divided by the number of weeks assessed.
6 secondary outcomes
Change in mean weekly VAS of low back pain
Time frame: Baseline, weeks 1-4, week 16 and week 28
Oswestry disability index
Time frame: Baseline, week 4, week 16 and week 28
Patients' global impressions of improvement
Time frame: week 4
Patients' expectations for acupuncture
Time frame: baseline
Blinded evaluation
Time frame: week 4
Incidence of serious adverse events
Time frame: up to 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Background: PubMed 17585160Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ. 2007 Jun 23;334(7607):1313-7. doi: 10.1136/bmj.39223.428495.BE. No abstract available.
- Background: PubMed 20227645Valat JP, Genevay S, Marty M, Rozenberg S, Koes B. Sciatica. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):241-52. doi: 10.1016/j.berh.2009.11.005.
- Background: PubMed 25806916Ropper AH, Zafonte RD. Sciatica. N Engl J Med. 2015 Mar 26;372(13):1240-8. doi: 10.1056/NEJMra1410151. No abstract available.
- Background: PubMed 22078311Lewis R, Williams N, Matar HE, Din N, Fitzsimmons D, Phillips C, Jones M, Sutton A, Burton K, Nafees S, Hendry M, Rickard I, Chakraverty R, Wilkinson C. The clinical effectiveness and cost-effectiveness of management strategies for sciatica: systematic review and economic model. Health Technol Assess. 2011 Nov;15(39):1-578. doi: 10.3310/hta15390. No abstract available.
- Background: PubMed 18032313Asche CV, Kirkness CS, McAdam-Marx C, Fritz JM. The societal costs of low back pain: data published between 2001 and 2007. J Pain Palliat Care Pharmacother. 2007;21(4):25-33.
- Background: PubMed 17545909Thomas KC, Fisher CG, Boyd M, Bishop P, Wing P, Dvorak MF. Outcome evaluation of surgical and nonsurgical management of lumbar disc protrusion causing radiculopathy. Spine (Phila Pa 1976). 2007 Jun 1;32(13):1414-22. doi: 10.1097/BRS.0b013e318060a5d1.
- Background: PubMed 26425130Ji M, Wang X, Chen M, Shen Y, Zhang X, Yang J. The Efficacy of Acupuncture for the Treatment of Sciatica: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:192808. doi: 10.1155/2015/192808. Epub 2015 Sep 6.
- Background: PubMed 26576192Qin Z, Liu X, Wu J, Zhai Y, Liu Z. Effectiveness of Acupuncture for Treating Sciatica: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2015;2015:425108. doi: 10.1155/2015/425108. Epub 2015 Oct 21.
- Background: PubMed 24239490Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.
- Background: PubMed 20954957MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, Moher D; STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. J Altern Complement Med. 2010 Oct;16(10):ST1-14. doi: 10.1089/acm.2010.1610.
- Background: PubMed 25501074Liu B, Xu H, Ma R, Mo Q, Yan S, Liu Z. Effect of blinding with a new pragmatic placebo needle: a randomized controlled crossover study. Medicine (Baltimore). 2014 Dec;93(27):e200. doi: 10.1097/MD.0000000000000200.
- Background: PubMed 12015843Porchet F, Wietlisbach V, Burnand B, Daeppen K, Villemure JG, Vader JP. Relationship between severity of lumbar disc disease and disability scores in sciatica patients. Neurosurgery. 2002 Jun;50(6):1253-9; discussion 1259-60. doi: 10.1097/00006123-200206000-00014.
- Individual participant dataSharing planned: Yes
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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.
Qin Yao principal investigator
Department of Acupuncture, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing (100053), China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Sciatica, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 12 May 2016. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qin Yao (+86-15650728152, 1126873424@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in mean weekly VAS of leg pain (time frame: Baseline, weeks 1-4, week 16 and week 28). 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 NCT02770963, which also lists 16 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 12 May 2016.