Heated Mittens for Patients With Hand Osteoarthritis

NCT04576403 | Completed

• 1 other identifier: 143 HOT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this trial is to assess the efficacy of an intervention with heated mittens in patients with hand osteoarthritis (HOA). The joints of the hands are some of the most commonly joints affected by osteoarthritis, together with hip and knee joints. The prevalence increases with age and as the elderly population is growing so will the number of persons with HOA. The primary symptoms for HOA are reduced function, stiffness and pain, with function being the most limiting factor for the patients. Pharmacological treatments have some effect. Non-pharmacological treatments (such as exercise) have been investigated in a limited number of studies with overall minimal effect on the primary symptoms. In the earlier days the use of heating interventions, such as paraffin bath, was common treatment for patients with arthritis. During the last decades a shift from heating to exercise oriented treatment has occurred, however seemingly with limited effect on the primary symptoms. American College of Rheumatology (ACR) newest published guideline for the management of HOA (2020) recommend heating as a treatment among others but without scientific sound evidence for effect. The hypothesis is that heated mittens worn at least 15 minutes every day for six weeks has a beneficial effect on physical function in patient with HOA when compared to placebo mittens (heat deactivated). This study is designed as a randomized controlled trial with two parallel groups (1:1) and physical function of the hand as primary endpoint after six weeks. The plan is to include 200 patients with HOA for this study. The intervention group will receive mittens with functioning heating elements; the control group will receive mittens without a functioning heating element. All participants are asked to wear the mittens for 6 weeks, 15 minutes each day. The primary endpoint is change in physical function of the hand, measured with the Australian/Canadian Osteoarthritis Hand Index (AUSCAN).

Conditions

Hand Osteoarthritis

Keywords

mittens; heat; hand osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Change in hand physical function

  change in physical function is measured with the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). AUSCAN is a validated questionnaire with 3 subscales assessing pain, hand stiffness and hand function during the last 48 hours. Each question is rated on a visual analog scale from 0 (no problems) to 100 (severe problems). The subscale function will be used.

  Baseline, week 6 (end-of-study)

Secondary Outcomes (5)

• Change in stiffness

  Baseline, week 6

• Change in tender and swollen joint count

  baseline, week 6

• Change in hand pain

  Baseline, week 6

• Change in global assessment of hand related problems

  Baseline, week 6

• Change in grip strength

  Baseline, week 6

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Activated mittens

Device: activated mittens

Control group

SHAM COMPARATOR

Deactivated mittens

Device: deactivated mittens

Interventions

activated mittens DEVICE

activated mittens (with electronic heat)

Intervention group

deactivated mittens DEVICE

deactivated mittens (without electronic heat)

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• HOA with fulfillment of the ACR criteria:
• a. Hand pain, aching or stiffness on most days the previous 4 weeks
• And at least 3 of the following features:
• Hard tissue enlargement of ≥2 of the 10 selected joints\*
• Hard tissue enlargement of ≥2 of the 10 DIP joints
• Fewer than 3 swollen metacarpophalangeal (MCP) joints
• Deformity of at least 1 of 10 selected joints\* \*The 10 selected joints are the second and third DIP, the second and third PIP, and the first carpometacarpal joints of both hands.
• AUSCAN Function ≥ 40 aggregated points (0-100 scale)
• Willing and able to participate in all study visits
• Able to understand and read Danish.

You may not qualify if:

• Other diseases affecting the joints of the hand (Rheumatoid arthritis, Psoriatic arthritis, ect.)
• Widespread or generalized pain syndrome (e.g. fibromyalgia)
• Steroid injections in the finger joints within the last month
• Other condition that in the opinion of the investigator makes the participant unsuitable for participation.

Sponsors & Collaborators

• Cecilie Bartholdy: lead

Study Sites (1)

Artroseambulatoriet

Frederiksberg, 2000, Denmark

Location

Related Publications (1)

• Bartholdy C, Dossing A, Stisen ZR, Nielsen SM, Christensen R, Danneskiold-Samsoe B, Bliddal H, Henriksen M, Ellegaard K. Effect of heated mittens on physical hand function in people with hand osteoarthritis: randomised controlled trial. BMJ. 2024 Dec 17;387:e078222. doi: 10.1136/bmj-2023-078222.

  PMID: 39689944 DERIVED

Study Officials

• cecilie bartholdy, PhD

  The Parker institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A designated person will number the all mittens using a randomization list. The rest of the study personnel (care provider, investigator, outcome assessor) will thereby not be aware of which mittens that functions and which that do not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: Participants will be randomised 1:1 to either intervention og control group by use of a randomization list

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: October 6, 2020
• Study Start: October 4, 2020
• Primary Completion: March 7, 2023
• Study Completion: March 7, 2023
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

DK (1)