Carpal Tunnel SyndromeNCT01014221
Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
A study testing Acupuncture and Prednisolone in people with Carpal Tunnel Syndrome, run by Kuang Tien General Hospital at 1 site in Taiwan.
Trial summary
To investigate the efficacy of acupuncture compared with steroid treatment in patients with mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled study. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Acupuncture and Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2007to Sep 2009
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of at least one of the following primary symptoms:
- numbness, tingling pain, or paresthesia in the median nerve distribution;
- precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand; and
- nocturnal awakening by such sensory symptoms.- plus the presence of 1 or more of the following standard electrophysiologic criteria:
- (1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB)(abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode);
- (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms; stimulation over the wrist, 14 cm proximal to the active electrode); and
- (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal <45 m/s).
Who cannot join
- symptoms occurring less than 3 months before the study or symptoms improving during the 1-month initial observation period (to exclude patients who might have spontaneous resolution of symptoms);
- severe CTS that had progressed to visible muscle atrophy;
- in our study, mild CTS referred to patients with decreased conduction velocity over the palm-wrist segment and delayed DSL, with normal median SNAP amplitude and CMAP amplitude of the APB. Moderate CTS referred to patients with abnormally delayed DML and DSL with either decreased median SNAP amplitude or decreased CMAP amplitude of the APB muscle. Thus, CTS patients with the presence of either fibrillation potentials or reinnervation on needle EMG in the APB were excluded (to ensure the inclusion of only mildly or moderately affected individuals);
- clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy;
- evidence of obvious underlying causes of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), use of vibrating machinery, and suspected malignancy or inflammation or autoimmune disease were documented as underlying causes for CTS;
- recent peptic ulcer or history of steroid intolerance;
- prior unpleasant experience with acupuncture or a bleeding diathesis; or
- cognitive impairment interfering with the patient's ability to follow instructions and describe symptoms.-
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the efficacy of acupuncture compared with steroid treatment in patients with mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled study.
Read the detailed description
A total of 77 consecutive and prospective CTS patients confirmed by NCS were enrolled in the study. Those who had fixed sensory complaint over the median nerve and thenar muscle atrophy were excluded. The CTS patients were randomly divided into 2 treatment arms: (1) 2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily (n =39), and (2)acupuncture administered in 8 sessions over 4 weeks (n=38). A validated standard questionnaire as a subjective measurement was used to rate the 5 major symptoms (pain, numbness, paresthesia,weakness/clumsiness, and nocturnal awakening) on a scale from 0 (no symptoms) to 10 (very severe). The total score in each of the 5 categories was termed the global symptom score (GSS). Patients completed standard questionnaires at baseline and 2 and 4 weeks later. The changes in GSS were analyzed to evaluate the statistical significance. NCS were performed at baseline and repeated at the end of the study to assess improvement. All main analyses used intent-to-treat.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Acupuncture, Prednisolone
- Keywords
- acupuncture, carpal tunnel syndrome, CTS, steroid, global symptom score (GSS)
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
acupuncture administered in 8 sessions over 4 weeks
PrednisoloneDrug
2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | acupuncture administered in 8 sessions over 4 weeks Receives: Other: Acupuncture |
| Steroid group | Active comparator | 2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global symptoms score (GSS)
Measured: Baseline, Month 1, 7, and 13
Secondary outcomes (1)
eletrophysiological parameters
Measured: baseline, month 1 and 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionSep 2009
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 Carpal Tunnel SyndromeStudies 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
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuang Tien General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014221
- Sponsor's protocol ID
- 9612
- Status last verified
- Nov 2009
- First submitted
- 13 Nov 2009
- Last updated
- 17 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Yang CP, Hsieh CL, Wang NH, Li TC, Hwang KL, Yu SC, Chang MH. Acupuncture in patients with carpal tunnel syndrome: A randomized controlled trial. Clin J Pain. 2009 May;25(4):327-33. doi: 10.1097/AJP.0b013e318190511c.
PubMed 19590482Yang CP, Wang NH, Li TC, Hsieh CL, Chang HH, Hwang KL, Ko WS, Chang MH. A randomized clinical trial of acupuncture versus oral steroids for carpal tunnel syndrome: a long-term follow-up. J Pain. 2011 Feb;12(2):272-9. doi: 10.1016/j.jpain.2010.09.001. Epub 2010 Nov 26.
PubMed 21111685
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01014221
- Acronym / sponsor ID
- 9612
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- acupuncture, carpal tunnel syndrome, CTS, steroid, global symptom score (GSS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Kuang Tien General HospitalUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 16 Nov 2009 (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.
To investigate the efficacy of acupuncture compared with steroid treatment in patients with mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled study.
Detailed description
A total of 77 consecutive and prospective CTS patients confirmed by NCS were enrolled in the study. Those who had fixed sensory complaint over the median nerve and thenar muscle atrophy were excluded. The CTS patients were randomly divided into 2 treatment arms: (1) 2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily (n =39), and (2)acupuncture administered in 8 sessions over 4 weeks (n=38). A validated standard questionnaire as a subjective measurement was used to rate the 5 major symptoms (pain, numbness, paresthesia,weakness/clumsiness, and nocturnal awakening) on a scale from 0 (no symptoms) to 10 (very severe). The total score in each of the 5 categories was termed the global symptom score (GSS). Patients completed standard questionnaires at baseline and 2 and 4 weeks later. The changes in GSS were analyzed to evaluate the statistical significance. NCS were performed at baseline and repeated at the end of the study to assess improvement. All main analyses used intent-to-treat.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupunctureacupuncture administered in 8 sessions over 4 weeks |
| Steroid group | Active comparator | Drug: Prednisolone2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- numbness, tingling pain, or paresthesia in the median nerve distribution;
- precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand; and
- nocturnal awakening by such sensory symptoms.- plus the presence of 1 or more of the following standard electrophysiologic criteria:
Key exclusion criteria (8 listed)
- symptoms occurring less than 3 months before the study or symptoms improving during the 1-month initial observation period (to exclude patients who might have spontaneous resolution of symptoms);
- severe CTS that had progressed to visible muscle atrophy;
- in our study, mild CTS referred to patients with decreased conduction velocity over the palm-wrist segment and delayed DSL, with normal median SNAP amplitude and CMAP amplitude of the APB. Moderate CTS referred to patients with abnormally delayed DML and DSL with either decreased median SNAP amplitude or decreased CMAP amplitude of the APB muscle. Thus, CTS patients with the presence of either fibrillation potentials or reinnervation on needle EMG in the APB were excluded (to ensure the inclusion of only mildly or moderately affected individuals);
- clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy;
- evidence of obvious underlying causes of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), use of vibrating machinery, and suspected malignancy or inflammation or autoimmune disease were documented as underlying causes for CTS;
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 |
|---|---|---|
| Acupunctureacupuncture administered in 8 sessions over 4 weeks | Other | Acupuncture group |
| Prednisolone2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily | Drug | Steroid group |
Primary outcome
Global symptoms score (GSS)
Time frame: Baseline, Month 1, 7, and 13
1 secondary outcome
eletrophysiological parameters
Time frame: baseline, month 1 and 13
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 17 Nov 2009.
- Results publication: PubMed 19590482Yang CP, Hsieh CL, Wang NH, Li TC, Hwang KL, Yu SC, Chang MH. Acupuncture in patients with carpal tunnel syndrome: A randomized controlled trial. Clin J Pain. 2009 May;25(4):327-33. doi: 10.1097/AJP.0b013e318190511c.
- Derived from this study: PubMed 21111685Yang CP, Wang NH, Li TC, Hsieh CL, Chang HH, Hwang KL, Ko WS, Chang MH. A randomized clinical trial of acupuncture versus oral steroids for carpal tunnel syndrome: a long-term follow-up. J Pain. 2011 Feb;12(2):272-9. doi: 10.1016/j.jpain.2010.09.001. Epub 2010 Nov 26.
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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 study testing Acupuncture and Prednisolone in people with Carpal Tunnel Syndrome, run by Kuang Tien General Hospital at 1 site in Taiwan.
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 7 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 17 Nov 2009. 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 Taiwan. 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?
Global symptoms score (GSS) (time frame: Baseline, Month 1, 7, and 13). 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 NCT01014221, 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 17 Nov 2009.