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Knee OsteoarthritisNCT01532531

The Effects of Collateral Meridian Therapy for Knee Osteoarthritis Pain Management

A study testing "GEMORE" Multi-Function Electrotherapy Stimulator in people with Knee Osteoarthritis and Pain, run by Taichung Armed Forces General Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Collateral meridian therapy (CMT) is a recently developed technique according to traditional Chinese medicine (TCM) experiences, differing from traditional Chinese acupuncture in numerous manners. CMT involves the manipulation of a distant non-painful collateral meridian, thereby facilitating the dissipation of pain. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Knee Osteoarthritis, Pain
What is being tested?
"GEMORE" Multi-Function Electrotherapy Stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteTaiwan
Study dates
Mar 2011to Dec 2011
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Knee OA patients aged 60 years or older
  • Visual analogue scale (VAS) pain score higher than 30 mm on a 100-mm scale over the medial side of the knee while walking

Who cannot join

  • Individuals who had undergone total knee arthroplasty, exhibited uncontrolled hypertension, had a history of cardiovascular disease, or suffered from neurological disorders that affected lower extremity functions were excluded from the study.
  • Patients who received conflicting or ongoing interventions such as acupuncture, hyaluronan injections, intra-articular corticosteroid, and transcutaneous electrical nerve stimulation and thermotherapy were also excluded.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Taichung Armed Forces General Hospital

    Taichung, 411

Other trials in Taiwan

About this study

Collateral meridian therapy (CMT) is a recently developed technique according to traditional Chinese medicine (TCM) experiences, differing from traditional Chinese acupuncture in numerous manners. CMT involves the manipulation of a distant non-painful collateral meridian, thereby facilitating the dissipation of pain. The technique avoids direct stimulation of the involved meridian, which enhances patient tolerability and prevents further injury to the disease and painful areas. Numerous clinical cases have reported the effectiveness of CMT in pain management. This study tests whether CMT is effective for treating knee OA pain and functional recovery.

Read the detailed description

Knee OA patients aged 60 years or older were recruited from the orthopedic clinic of Taichung Armed Force General Hospital, Taichung, Taiwan. All the patients had been clinically and radiologically diagnosed with knee OA according to the criteria of the American College of Rheumatology and Lawrence radiographic changes in the tibiofemoral joint by using a visual analogue scale (VAS) pain score higher than 30 mm on a 100-mm scale over the medial side of the knee while walking. Individuals who had undergone total knee arthroplasty, exhibited uncontrolled hypertension, had a history of cardiovascular disease, or suffered from neurological disorders that affected lower extremity functions were excluded from the study. Patients who received conflicting or ongoing interventions such as acupuncture, hyaluronan injections, intra-articular corticosteroid, and transcutaneous electrical nerve stimulation and thermotherapy were also excluded. Patients under drug treatment were included if no changes in medication had occurred, and the dosages had been administered for one month or longer. Oral paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) were permitted as rescue pain medications for the duration of the study. Rescue pain medications or any change in medicines and dosages were recorded. This study was approved by the IRB of Tri-Service General Hospital, Taipei, Taiwan and written informed consents were obtained from the enrolled participants. According to the sealed envelop method, the enrolled patients were randomly allocated to the control group or CMT group.

Treatment CMT group The CMT group patients received, according to the CMT protocol described previously, CMT at the selected points with the CMT Electrotherapy Stimulator ("GEMORE" Multi-Function Electrotherapy Stimulator; GM390TE, GEMORE Co Ltd, Taiwan) to treat the affected OA knee. In brief, knee OA mostly induced knee pain at the medial side, the corresponding disease meridian of OA is AxI/3, the first yin meridian (AxI) over knee region ("3") on the medial aspect of the lower extremity (the spleen meridian in TCA). A reduction technique, to remove the obstructed overflowed Qi, was performed by treating the point "3" on the ipsilateral third yang meridian (TyIII) over the dorsal aspect of the upper extremity (TyIII/3:3), which corresponded to Tze Cheng (SI7) on the small intestine meridian in TCA; the aspect shares the same control C-point (the first "3" ) and F-point (the second "3") to divert the obstructed Qi from obstructed diseased meridian to the healthy one; the C-point is used to link the diseased meridian to the treatment healthy meridian; manipulating the F-point is for the treatment/removal of the disease/pain symptom. An enhancement technique was performed by treating contralateral meridian "Ax II/2:(3)," which represents treating "2" as the C-point and "3" as the F-point, and a number in parentheses signifies usage of enhancement technique on the contralateral second yin meridian of the medial aspect of the lower extremity (corresponding to San Yin Jiao (SP6) and Lou Ku (SP7), respectively, on the liver meridian in TCA). The 6-minute treatment (electrotherapy was set at 40 Hz biphasic and 30 mA) comprises reduction and enhancement procedures on the specific points (figures 1 and 2). Each patient received CMT twice per week for three weeks during the study.

Control (CT) group The patients in the CT group received electronic lead-patches applied on the treatment points, which was identical to what the CMT group received, also for 6 minutes, though no electric stimulation was applied.

Evaluation of outcomes Primary outcome measures were: (1) pain intensity at activity, quantified with a 100 mm VAS and (2) pain disability measured with the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC, 0-96 points). The WOMAC is a disease-specific measure of pain, stiffness, and physical function for individuals with knee OA. The WOMAC comprises 5 items related to pain, 2 items related to stiffness, and 17 items related to physical function. Each item is scored on a 5-point Likert scale (0-4). The reliability and validity of WOMAC scores have been established. The VAS and WOMAC scores were measured immediately by independent staff before the first treatment, and subsequently at one, two, three weeks, and three months after the first treatment.

Statistical analysis Patients were excluded from analysis if they were not present for the follow-up, or the outcomes were not assessed. The Mann-Whitney test was employed to analyze differences between the VAS and WOMAC scores of the two groups. SPSS software for Windows was used for statistical analysis. All the data are presented as means (±SD). The data with P values less than 0.05 are considered statistically significant.

Being tested
"GEMORE" Multi-Function Electrotherapy Stimulator
Keywords
Collateral Meridian Therapy, Knee Osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "GEMORE" Multi-Function Electrotherapy StimulatorDevice

    The Collateral Meridian Therapy (CMT) group patients received, according to the CMT protocol described previously (5), CMT at the selected points with the CMT Electrotherapy Stimulator ("GEMORE" Multi-Function Electrotherapy Stimulator; GM390TE, GEMORE Co Ltd, Taiwan) to treat the affected OA knee. The 6-minute treatment (electrotherapy was set at 40 Hz biphasic and 30 mA) comprises reduction and enhancement procedures on the specific points. Each patient received CMT twice per week for three weeks during the study.

Study groups in NCT01532531
Study groupRoleWhat they receive
Collateral Meridian TherapyExperimentalThe CMT group patients received, according to the CMT protocol described previously, CMT at the selected points with the CMT Electrotherapy Stimulator ("GEMORE" Multi-Function Electrotherapy Stimulator; GM390TE, GEMORE Co Ltd, Taiwan) to treat the affected OA knee. The 6-minute treatment (electrotherapy was set at 40 Hz biphasic and 30 mA) comprises reduction and enhancement procedures on the specific points. Each patient received CMT twice per week for three weeks during the study.
Receives: Device: "GEMORE" Multi-Function Electrotherapy Stimulator
Control (CT) groupNo interventionPatients in the CT group received electronic lead-patches applied on the treatment points, which was identical to what the CMT patients received, also for 6 minutes, though no electric stimulation was applied.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Western Ontario and McMaster Universities Osteoarthritis Index, visual analogue scale

    ain intensity at activity, quantified with a 100 mm VAS and pain disability measured with the Western Ontario and McMasters Universities Osteoarthritis Index. The VAS and WOMAC scores were measured immediately by independent staff before the first treatment, and subsequently at one, two, three weeks, and three months after the first treatment.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2012 (estimated)
  2. Study startMar 2011
  3. Primary completionSep 2011
  4. Study completionDec 2011

Resources

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
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01532531
Sponsor's protocol ID
TC98-2
Status last verified
Aug 2012
First submitted
7 Feb 2012
Last updated
15 Aug 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing "GEMORE" Multi-Function Electrotherapy Stimulator in people with Knee Osteoarthritis and Pain, run by Taichung Armed Forces 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 2 inclusion and 2 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 15 Aug 2012. 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?

Western Ontario and McMaster Universities Osteoarthritis Index, visual analogue scale (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Aug 2012.

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