Focal Thermal Therapy Acupoint OA Knee RCT

NCT04735029 | Completed DMC

• 1 other identifier: 2016.555-T
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoarthritis of the knee is a common degenerative joint disorder in our ageing population. A combination of thermal therapy with a self-management exercise have shown a positive effect in the management of osteoarthritis of the knee. This study aimed to compare the effectiveness of topical heat pack versus focal application of heat therapy at the acupressure points in the treatment of osteoarthritis of the knee.

Conditions

Osteoarthritis, Knee; Randomized Controlled Trial

Keywords

knee osteoarthritis; acupuncture; randomized control trial

Outcome Measures

Primary Outcomes (10)

• Visual analogue scale (VAS) for pain

  10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.

  Baseline

• Visual analogue scale (VAS) for pain

  10-scale likert scale to measure pain level visually; Minimum = 0 and Maximum value = 10, and higher scores mean a better outcome.

  After 1 year

• Knee range of movement (ROM)

  Knee range of movement (ROM) in the supine position using a goniometer; Numeric

  Baseline

• Knee range of movement (ROM)

  Knee range of movement (ROM) in the supine position using a goniometer; Numeric

  After 1 year

• Quadriceps and hamstrings muscle strength

  Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric

  Baseline

• Quadriceps and hamstrings muscle strength

  Quadriceps and hamstrings muscle strength were measured according to the Oxford Scale of Muscle Strength; Numeric

  After 1 year

• Western Ontario and McMasters Universities (WOMAC)

  Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric

  Baseline

• Western Ontario and McMasters Universities (WOMAC)

  Functional assessment with the validated Chinese version of the Western Ontario and McMasters Universities (WOMAC); Numeric

  After 1 year

• Short Form-12 version 2 (SF-12v2)

  Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome

  Baseline

• Short Form-12 version 2 (SF-12v2)

  Quality of life evaluation; Expressed by Physical component summary (PCS) and Mental component summary (MCS); Both numeric, The higher score the better outcome

  After 1 year

Study Arms (2)

Thermal Gun group

EXPERIMENTAL

The thermal gun applied on acupressure points in TCM. The thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.

Device: Thermal gun

Heat Pack group

ACTIVE COMPARATOR

A hydrocollator heat pack used to simulate traditional thermal therapy. The application of the heat pack was wrapped with six layers of terry towels to bring the temperature down to around 43°C.

Other: Heat pack

Interventions

Thermal gun DEVICE

Thermal gun used a heat-generating ceramic head to apply a dual effect called "heat-and-light-pressure" on the acupuncture points.

Thermal Gun group

Heat pack OTHER

A hydrocollator heat pack used to simulate traditional thermal therapy

Heat Pack group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female patients aged 40 years old or older
• clinical and radiological diagnosis of osteoarthritis of the knee based on the OA Knee clinical guidelines and radiological evidence
• normal skin sensation to heat, cold, pins and pricks (i.e. passed the required Skin Sensation Test)
• not participating in any other clinical trial at time of this study
• be able to complete the whole trial period
• no cognitive dysfunction and was able to sign the consent form

You may not qualify if:

• received bilateral knee arthroplasty before this study
• polyarthritis affecting more than both knee
• active skin lesion
• women in pregnancy or breasts feeding
• received acupuncture and/or moxibustion within one month of the study
• unable to comply with the study protocol

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Publications (1)

• Ho KK, Kwok AW, Chau WW, Xia SM, Wang YL, Cheng JC. A randomized controlled trial on the effect of focal thermal therapy at acupressure points treating osteoarthritis of the knee. J Orthop Surg Res. 2021 Apr 27;16(1):282. doi: 10.1186/s13018-021-02398-2.

  PMID: 33906695 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Kevin Ki-Wai Ho

  Chinese University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Envelope
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professional Consultant

Model Details: Group 1: Heat pack group; Group 2: Thermal Gun group

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: January 1, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share