Warm Needle Acupuncture vs Needle Acupuncture

NCT02680912 | Unknown

• 1 other identifier: 6505
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-armed randomised controlled pilot study that investigates the component efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to receive either warm needle acupuncture or needle acupuncture. Participants and acupuncturists will be blinded to group allocation. The primary and secondary outcome measures are WOMAC and SF36 respectively. Qualitative interviews will be used to gather information on the patients' experiences and perceptions of the trial and the treatment provided. It is hypothesised that warm needle acupuncture will lead to a greater reduction in clinical signs and symptoms than needle acupuncture.

Conditions

Osteoarthritis, Knee

Keywords

Bi syndrome

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Change from Baseline to follow up at 16 weeks

Secondary Outcomes (1)

• SF36 (Rand)

  Change from Baseline to follow up at 16 weeks

Study Arms (2)

Warm needle acupuncture

EXPERIMENTAL

Warm needle acupuncture (wenzhen; 温针) is where moxa cones are placed on the handle of the needle, after the needle has been inserted. Once lit, heat transmits along the shaft of the needle to the acupuncture point. Moxa refers to the herb mugwort (Artemisia vulgaris) that is burnt to warm specific parts of the body, including acupuncture points.

Device: Warm needle acupuncture

Basic needle acupuncture

ACTIVE COMPARATOR

Basic needle acupuncture is the use of acupuncture needles alone, without other methods of stimulation.

Device: Needle acupuncture

Interventions

Warm needle acupuncture DEVICE

There will be 4-6 points used per knee, therefore 8-12 needles per treatment. Two points will be used as the core treatment ST 35 dubi, Ex-LE 5 xiyan. Four other acu-points can also be used from the following: Ahshi painful points local to the knee (locus dolendi), ST 36 zusanli, GB 34 yanglingquan, Sp 9 yinlingquan, ST34 liangqiu, Sp 10 xuehai, GB 33 yangxiguan, LR 7 xiguan, LR 8 ququan, heding Ex-LE 2 In addition to the acupuncture needles the warm needle acupuncture group will receive moxibustion on up to 4 points. Smokeless moxa will be used.

Warm needle acupuncture

Needle acupuncture DEVICE

The point selection protocol will be exactly the same as the experimental group

Basic needle acupuncture

Eligibility Criteria

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

You may qualify if:

• Chronic pain in at least one knee joint during the last six months.
• At baseline the WOMAC pain score must be ≥ 3 points (on a scale of 0-10)
• In addition to the knee pain at least 3 of the following 6 must be present:
• Age \> 50 years
• Stiffness \< 30 minutes
• Crepitus
• Bony Tenderness
• Bony enlargement
• No palpable warmth
• (ACR 2013)
• Plus
• Ability to speak English
• Signed consent form

You may not qualify if:

• A systemic disease of the musculoskeletal system.
• Bone tumour, bone tumour like lesions or metastasis.
• Bone fracture in the lower extremities during the last three months.
• Acute infection or osteonecrosis in the knee joint.
• Recent sprain injury to the knee joint.
• Surgery of the afflicted extremity during the last six months or planned surgery.
• Ongoing cortico-steroid therapy or cortisone injections in the past six weeks.
• Taking anti-coagulant medication.
• Coagulopathy.
• Other pain condition that compels the patient to take analgesics for more than three days during the last four weeks.
• Addiction to analgesics, opiate or other drugs.
• Acupuncture treatment in the past 3 months.
• Dermatological disease within the acupuncture area impairing acupuncture treatment.
• Pregnant or breast-feeding patients.
• Inability to follow instructions or understand the consent form (insufficient command of language, dementia).

Sponsors & Collaborators

• London South Bank University: lead
• British Acupuncture Council: collaborator
• Confucius Institute for Traditional Chinese Medicine, London South Bank University: collaborator

Study Sites (1)

Confucius Institute for TCM LSBU

London, SE1 0AA, United Kingdom

Location

Related Links

• WOMAC Osteoarthritis Index
• ACR 2013, "Classification Criteria for Rheumatic Diseases: Idiopathic OA of the knee", American College of Rheumatology, \[Online\], , pp. 5 January 2014.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Ian K Appleyard

  London South Bank University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 12, 2016
• Study Start: February 1, 2016
• Primary Completion: May 16, 2017
• Study Completion: July 1, 2017
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)