Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04576403 |
| Other study ID # |
143 HOT |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 4, 2020 |
| Est. completion date |
March 7, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Frederiksberg University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
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. Approximately 40% of adults have both self-reported and
X-ray conformed signs of HOA. The prevalence increases with age and as the elderly population
is growing so will the number of persons with HOA.
HOA is a heterogeneous disease with varying levels of symptoms and joint involvement. The
most frequently affected joints are the carpometacarpal (CMC) 1 joints together with the
distal interphalangeal (DIP), less frequent the proximal interphalangeal (PIP) joints. The
primary symptoms are reduced function, stiffness and pain.
Pharmacological treatments have limited 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, were common treatment for patients with arthritis. During the last decades a
shift from heating to exercise oriented treatment have 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.
An interview have been conducted at the Parker Institute with people suffering from HOA and
all agreed that head was their preferred treatment for symptom reduction. They also stated
that heat could reduce stiffness of the fingers. Heating therapy is assumed to provide
analgesic effect and decrease muscle tonicity. Two studies have investigated the sort term
effect of heat wrap therapy on low back and wrist pain compared to ibuprofen or placebo
medication, respectively. In both studies the effect of the heat wrapping therapy was
superior to the control group in reducing pain and increasing motion. This suggests that
there is a short-term effect of heating therapy in musculoskeletal conditions.
The inflammation level in HOA fluctuates it therefore could be argued that heating therapy
may reinforce present inflammation and should be avoided during flares. However, in persons
with rheumatoid arthritis heat do not seem to increase the inflammation markers in the
synovial tissue.
Studies assessing the potential benefits of non-pharmacological treatments of HOA are scares
and both ACR (American College of Rheumatology), EULAR (European League against Rheumatism)
and OARSI (Osteoarthritis Research Society International) recommend exploration of this area.
Thus, it is relevant to develop and implement treatment strategies for the management of HOA
in order to optimize current treatment strategies.
Based on previous treatment strategies and recent recommendations it seems relevant to
investigate if a daily intervention with warm mittens can help reduce pain, improve function
and reduce stiffness in patients with HOA.
The aim of this randomized controlled study is to assess the effect of heated mittens after 6
weeks on physical function in patients with HOA.
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).
STUDY DESIGN This study is designed as a randomised controlled trial with two parallel groups
and physical function of the hand as primary endpoint after six weeks.
For each study participant, participation is 6 weeks with clinical assessments at baseline
and after 6 weeks.
The number of study participants to be randomised for this study is 200 based on a sample
size calculation (see section 14.1). Randomised participants who withdraw during study
participation or who are prematurely terminated will not be replaced.
Randomization lists will be computer-generated based upon permuted random blocks of variable
size (2 to 6 in each block). The allocation ratio will be 1:1 stratified for the following
baseline conditions:
A. CMC 1 OA B. Grip strength
The investigators, outcome assessors, and participants will be blinded to treatment
allocation.
The persons performing the phone calls at week 2 and 4 will not be blinded to the allocation.
The HOT intervention consists of a pair of mittens with heating elements. The mittens are
produced by Nordic Heat Aps, Denmark. The intensity of the heat can be adjusted by use of a
button placed at the dorsal side of the mittens. The mittens have three intensities: red=max,
yellow=medium and green=minimum.
The participants are instructed to wear the mittens at least 15 minutes every day, preferably
in the morning, for six weeks. If the participants want to use the mittens several times per
day or longer than 15 minutes they can. Participants will be instructed to fill out a diary
during the intervention period containing the following information; number of times per day
they wear the mittens, duration of each wear-time, and intensity level.
Two batteries are placed in the bottom of the mittens with a wire connecting them to the
heating element. The batteries must be charged every day, using a charger. In addition to the
mittens all participants will receive three pairs of thin cotton gloves (Abena A/S, Aabenraa,
Denmark) to use under the mittens for better distribution of the heat.
The mittens, charger, cotton gloves, and diary will be handed out at the baseline visit,
after randomization, together with oral and written instructions.
Participants in the control group will receive the same type of mittens but with the heating
element being deactivated. Further they will receive cotton gloves to wear underneath the
mittens. Both groups will receive the same oral and written instructions on who to use the
mittens and all will be instructed to fill out a diary. Participants in both groups will
receive a phone call at week 2 and 4 to maintain compliance.
Statistics Sample size A sample size of 200 in total will provide strong statistical power to
detect differences between groups in favour of heated mittens. For a two-sample pooled t-test
of a normal mean difference with a two-sided significance level of 0.05 (P<0.05), assuming a
common standard deviation of 19 AUSCAN-function points (0-100 scale), a total sample size of
180 assuming a balanced design has a power of 80.2% to detect a mean difference of 8
AUSCAN-function points (corresponding to a small effect size of 0.42). To account for
dropouts, 200 patients will be included.
Primary analysis population The intention to treat (ITT) population consist of all randomized
patients irrespective of whether the patient actually received study intervention or the
patient's compliance with the study protocol, in the treatment group to which the participant
was assigned at randomisation. A patient will be considered randomised as soon as a treatment
is assigned.
Statistical approach A statistical analysis plan that describes the details of the planned
statistical analyses will be produced before last patient's last visit.
Assessments of changes from baseline and construction of confidence intervals (CI) for
continuous measures will be based on a repeated measures analysis of covariance (ANCOVA;
including group as the main factor and baseline measure as covariate). Superiority will be
claimed if the computed 95% CI of the estimated group difference in the change from baseline
in the AUSCAN does not include 0 in the ITT population. All statistical tests will be
two-sided and statistical significance will be claimed if the computed p-value is equal to or
less than 0.05.
Case report forms (CRF) The study will use electronic case report forms (eCRF) using an
in-house database created specifically to this trial by the Parker Institutes database
manager. To additional program will be used to capture the questionnaire registrations
electronically: RedCap will be used to supply data from home (AUSCAN send at week 2 and 4),
Cirkeline will be used to supply data from the study visits (baseline, week 6).
In addition to the eCRF a paper based CRF is created to allow for on-the-go registration of
participants at the clinic. An investigator will be responsible for the transfer of data from
the CRF to eCRF during the trial period.
At the end of the trial, all data will be merged and stored in the in-house database. The
in-house database meets all regulatory standards and allows management of all activities
related to clinical trials that ensures optimal resource use and safety according to good
clinical practice and data protection legislation.
Quality assurance All data will be entered into a study database for analysis and reporting.
Any data captured electronically will be stored electronically in a separate database
according to standard procedures at The Parker Institute. Upon completion of data entry, the
databases will be checked to ensure acceptable accuracy and completeness. System backups and
record retention for the study data will be consistent with The Parker Institute standard
procedures.
Data protection and regulation The study will be conducted in accordance with the Data
Protection Act and follow the General Data Protection Regulation. The study data management
and data security procedures are approved by the Regional Knowledge Centre on Data Protection
Compliance (videnscenter for dataanmeldelser i Region Hovedstaden) on behalf of the Danish
Data Protection agency.
