SciaticaNCT02384928
Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation
A study testing Shinbaro pharmacopuncture, Acupuncture and Conventional medicine in people with Sciatica and Intervertebral Disc Displacement, run by Jaseng Medical Foundation at 1 site in South Korea.
Trial summary
This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Sciatica, Intervertebral Disc Displacement
- What is being tested?
- Shinbaro pharmacopuncture, Acupuncture and Conventional medicine
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Sep 2015to 16 Mar 2017
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sciatica patients with an average sciatic pain NRS of 5 or higher during the preceding 3 days
- Onset of at least 4 weeks previous for current sciatic pain episode
- Patients whose sciatic symptoms correlate with the LDH confirmed on MRI
- Patients who have agreed to follow the trial protocol
Who cannot join
- Patients who have received invasive treatments such as nerve blocks, pharmacopuncture, or acupuncture within the past week
- Non-spinal or soft tissue pathologies which may cause LBP or sciatic pain (e.g. spinal tumors, rheumatic arthritis)
- Pregnancy
- History of spinal surgery, or spinal pathologies other than LDH (e.g. spinal dislocation, fracture)
- Severe progressive neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
- Patients for whom acupuncture may be inappropriate or unsafe (e.g. hemorrhagic diseases, blood clotting disorders, history of anti-coagulation medicine, severe diabetes with risk of infection, severe cardiovascular diseases or other conditions deemed unsuitable)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation: a Three-armed, Randomized, Double-blind Controlled Pilot Study
This trial will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, 4 weeks - 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture, acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks, and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.
Read the detailed description
This study is a three-armed, randomized, patient, physician, and assessor-blinded, controlled pilot to the aim of evaluating the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, onset between 4 weeks and 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture (pharmacopuncture+acupuncture), acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks (total 8 sessions), and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy (total 8 sessions). The initial acupuncture physician will administer acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) in the 2 acupuncture groups, and mark an additional acupoint. A second acupuncture physician will administer pharmacopuncture to the marked acupoint in the pharmacopuncture group, and acupuncture in the acupuncture group. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.
- Conditions
- Sciatica, Intervertebral Disc Displacement
- Being tested
- Shinbaro pharmacopuncture, Acupuncture, Conventional medicine, Physical therapy, Educational program
- Keywords
- Acupuncture, Pharmacopuncture, Usual Care
- Medical subject headings
- Sciatica, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shinbaro pharmacopunctureProcedure or surgery
Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints. One Hyeopcheok (Huatuo Jiaji, EX B2) acupoint most relevant to patient symptoms with reference to MRI will be administered Shinbaro pharmacopuncture.
AcupunctureDevice
Five acupoints will be needled to about 1cm depth assisted by an acupuncture guide tube with no manual stimulation such as twirling or lifting and thrusting.
Conventional medicineDrug
Also called Conventional drugs
Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics. The most frequently prescribed conventional drugs for LDH include aceclofenac (Drug class: nonsteroidal antiinflammatoy drugs (NSAIDs)), tramadol hydrochloride (Drug class: Opioids), talniflumate (Drug class: NSAIDs), diclofenac sodium (Drug class: NSAIDs), and loxoprofen sodium (Drug class: NSAIDs).
Physical therapyProcedure or surgery
Also called Physiotherapy
Physical therapy will be prescribed with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics.
Educational programBehavioural
Educational program sessions supervised by physicians will be provided once a week for 4 weeks.The education program will inform the patient of the favorable prognosis of LDH, and instructions for everyday activities and self-management. The education program will consist of handbooks handed out to each participant, and weekly reminders and encouragement from the physician.
| Study group | Role | What they receive |
|---|---|---|
| Shinbaro pharmacopuncture group | Experimental | The Shinbaro pharmacopuncture group will receive 8 interventional sessions of Shinbaro pharmacopuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week. Receives: Procedure: Shinbaro pharmacopuncture; Device: Acupuncture; Behavioral: Educational program |
| Acupuncture group | Active comparator | The acupuncture group will receive 8 interventional sessions of acupuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and 5 other acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week. Receives: Device: Acupuncture; Behavioral: Educational program |
| Usual care group | Active comparator | The usual care group will receive conventional medicine 2 times/day and 2 sessions/week of physical therapy over 4 weeks. Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics, which include aceclofenac, tramadol hydrochloride, talniflumate, diclofenac sodium, and loxoprofen sodium. All groups will take 4 educational program sessions supervised by physicians once a week. Receives: Drug: Conventional medicine; Procedure: Physical therapy; Behavioral: Educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale (VAS) of sciatic pain
On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
Measured: Week 5
Secondary outcomes (9)
Visual analogue scale (VAS) of sciatic pain
On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
Measured: Week 1, 2, 3, 4, 7, 9, 12
Visual analogue scale (VAS) of low back pain (LBP)
On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
Measured: Week 1, 2, 3, 4, 5, 7, 9, 12
Numeric rating scale (NRS) of low back pain (LBP)
The patient choose number between 0 to 10, which represent the serverity of the pain that he felt. 0 means there's no pain, and 10 means there's severe pain that he ever felt.
Measured: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
Numeric rating scale (NRS) of sciatic pain
The patient choose number between 0 to 10, which represent the serverity of the pain that he felt. 0 means there's no pain, and 10 means there's severe pain that he ever felt.
Measured: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is an index is derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The ODI is a 10-item score from 0 to 100 that encompasses limitations in activity, sleeping, social life, work, and personal care resulting from low back pain.
Measured: Week 1, 2, 3, 4, 5, 7, 9, 12
Short Form Health Survey 36 (SF-36)
SF-36 Questionnaire consists of several questions related to local pain, radiationg pain, analgesic intake and ability.
Measured: Week 1, 5, 7, 12
EuroQol-5 Dimension (EQ-5D)
Estimates that shows the quality of life(QOL).
Measured: Week 1, 5, 7, 12
Patient Global Impression of Change (PGIC)
This scale evaluates all aspects of patients' health and assesses if there has been an improvement or decline in clinical status.
Measured: Week 1, 5, 7, 12
Number and percentage of participants with adverse events
The number and percentage of participants with adverse events, categorized by affected body region, will be reported.
Measured: Week 1, 2, 3, 4, 5, 7, 9, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start9 Sep 2015
- Primary completion31 Jan 2017
- Study completion16 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- Jinho Lee, Principal investigator, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384928
- Sponsor's protocol ID
- JS-CT-2015-03
- Status last verified
- Jul 2022
- First submitted
- 27 Feb 2015
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lee J, Shin JS, Lee YJ, Kim MR, Ahn YJ, Park KB, Kropf MA, Shin BC, Lee MS, Ha IH. Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:455. doi: 10.1186/s13063-015-0993-6.
PubMed 26459006
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shinbaro Pharmacopuncture in Sciatic Pain Patients With Lumbar Disc Herniation: a Three-armed, Randomized, Double-blind Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT02384928
- Acronym / sponsor ID
- JS-CT-2015-03
- Conditions
- Sciatica, Intervertebral Disc Displacement
- Keywords
- Acupuncture, Pharmacopuncture, Usual Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 16 Mar 2017 (actual)
- First posted
- 10 Mar 2015 (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 will evaluate the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, 4 weeks - 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture, acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks, and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.
Detailed description
This study is a three-armed, randomized, patient, physician, and assessor-blinded, controlled pilot to the aim of evaluating the comparative clinical effectiveness of pharmacopuncture for severe non-acute sciatic pain patients diagnosed with lumbar disc herniation (LDH) with usual care of conventional medicine and that of Korean medicine (acupuncture). Sixty patients with severe non-acute sciatic pain patients diagnosed with LDH (NRS ≥5, onset between 4 weeks and 6 months) will be recruited, and randomized 20 each to the Shinbaro pharmacopuncture (pharmacopuncture+acupuncture), acupuncture, and usual care group, respectively. The 2 acupuncture groups will receive 2 sessions/week of acupuncture alone or with pharmacopuncture for 4 weeks (total 8 sessions), and the usual care group will receive conventional medication 2 times/day and 2 sessions/week of physical therapy (total 8 sessions). The initial acupuncture physician will administer acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) in the 2 acupuncture groups, and mark an additional acupoint. A second acupuncture physician will administer pharmacopuncture to the marked acupoint in the pharmacopuncture group, and acupuncture in the acupuncture group. Post-treatment evaluations will take place 5, 7, 9, and 12 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shinbaro pharmacopuncture group | Experimental | Procedure: Shinbaro pharmacopuncture, Device: Acupuncture, Behavioral: Educational programThe Shinbaro pharmacopuncture group will receive 8 interventional sessions of Shinbaro pharmacopuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and acupuncture at 5 acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week. |
| Acupuncture group | Active comparator | Device: Acupuncture, Behavioral: Educational programThe acupuncture group will receive 8 interventional sessions of acupuncture at one Hyeopcheok (Huatuo Jiaji, EX B2) point and 5 other acupoints (GB30, BL40, BL25, BL23, GB34) 2 times/week over 4 weeks. All groups will take 4 educational program sessions supervised by physicians once a week. |
| Usual care group | Active comparator | Drug: Conventional medicine, Procedure: Physical therapy, Behavioral: Educational programThe usual care group will receive conventional medicine 2 times/day and 2 sessions/week of physical therapy over 4 weeks. Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics, which include aceclofenac, tramadol hydrochloride, talniflumate, diclofenac sodium, and loxoprofen sodium. All groups will take 4 educational program sessions supervised by physicians once a week. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Sciatica patients with an average sciatic pain NRS of 5 or higher during the preceding 3 days
- Onset of at least 4 weeks previous for current sciatic pain episode
- Patients whose sciatic symptoms correlate with the LDH confirmed on MRI
- Patients who have agreed to follow the trial protocol
Key exclusion criteria (6 listed)
- Patients who have received invasive treatments such as nerve blocks, pharmacopuncture, or acupuncture within the past week
- Non-spinal or soft tissue pathologies which may cause LBP or sciatic pain (e.g. spinal tumors, rheumatic arthritis)
- Pregnancy
- History of spinal surgery, or spinal pathologies other than LDH (e.g. spinal dislocation, fracture)
- Severe progressive neurologic symptoms (e.g. cauda equina syndrome, progressive muscle weakness)
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 |
|---|---|---|
| Shinbaro pharmacopuncturePharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints. One Hyeopcheok (Huatuo Jiaji, EX B2) acupoint most relevant to patient symptoms with reference to MRI will be administered Shinbaro pharmacopuncture. | Procedure or surgery | Shinbaro pharmacopuncture group |
| AcupunctureFive acupoints will be needled to about 1cm depth assisted by an acupuncture guide tube with no manual stimulation such as twirling or lifting and thrusting. | Device | Acupuncture group, Shinbaro pharmacopuncture group |
| Conventional medicineAlso: Conventional drugsConventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics. The most frequently prescribed conventional drugs for LDH include aceclofenac (Drug class: nonsteroidal antiinflammatoy drugs (NSAIDs)), tramadol hydrochloride (Drug class: Opioids), talniflumate (Drug class: NSAIDs), diclofenac sodium (Drug class: NSAIDs), and loxoprofen sodium (Drug class: NSAIDs). | Drug | Usual care group |
| Physical therapyAlso: PhysiotherapyPhysical therapy will be prescribed with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics. | Procedure or surgery | Usual care group |
| Educational programEducational program sessions supervised by physicians will be provided once a week for 4 weeks.The education program will inform the patient of the favorable prognosis of LDH, and instructions for everyday activities and self-management. The education program will consist of handbooks handed out to each participant, and weekly reminders and encouragement from the physician. | Behavioural | Acupuncture group, Shinbaro pharmacopuncture group, Usual care group |
Primary outcome
Visual analogue scale (VAS) of sciatic pain
Time frame: Week 5
On the 10cm line which represent the severity of pain, the patient mark point which best represent the severity that he feels.
9 secondary outcomes
Visual analogue scale (VAS) of sciatic pain
Time frame: Week 1, 2, 3, 4, 7, 9, 12
Visual analogue scale (VAS) of low back pain (LBP)
Time frame: Week 1, 2, 3, 4, 5, 7, 9, 12
Numeric rating scale (NRS) of low back pain (LBP)
Time frame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
Numeric rating scale (NRS) of sciatic pain
Time frame: Baseline(screening), Week 1, 2, 3, 4, 5, 7, 9, 12
Oswestry Disability Index (ODI)
Time frame: Week 1, 2, 3, 4, 5, 7, 9, 12
Short Form Health Survey 36 (SF-36)
Time frame: Week 1, 5, 7, 12
EuroQol-5 Dimension (EQ-5D)
Time frame: Week 1, 5, 7, 12
Patient Global Impression of Change (PGIC)
Time frame: Week 1, 5, 7, 12
Number and percentage of participants with adverse events
Time frame: Week 1, 2, 3, 4, 5, 7, 9, 12
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 26 Jul 2022.
- Derived from this study: PubMed 26459006Lee J, Shin JS, Lee YJ, Kim MR, Ahn YJ, Park KB, Kropf MA, Shin BC, Lee MS, Ha IH. Effects of Shinbaro pharmacopuncture in sciatic pain patients with lumbar disc herniation: study protocol for a randomized controlled trial. Trials. 2015 Oct 12;16:455. doi: 10.1186/s13063-015-0993-6.
- Individual participant dataSharing planned: No
Related trials for Sciatica
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
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.
Jinho Lee principal investigator
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shinbaro pharmacopuncture, Acupuncture and Conventional medicine in people with Sciatica and Intervertebral Disc Displacement, run by Jaseng Medical Foundation at 1 site in South Korea.
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 4 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: finished, as of the sponsor's last update on 26 Jul 2022. 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 South Korea. 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.
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?
Visual analogue scale (VAS) of sciatic pain (time frame: Week 5). 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 NCT02384928, which also lists 1 linked publication.
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 26 Jul 2022.