Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000696392
Ethics application status
Approved
Date submitted
2/05/2017
Date registered
15/05/2017
Date last updated
27/03/2019
Date data sharing statement initially provided
27/03/2019
Date results information initially provided
27/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Joint mobilization of the hands in rheumatoid arthritis: an assessor-blinded, randomized crossover study
Scientific title
Joint mobilization of the hands as a potential method for reducing pain and improving ultrasound outcomes in patients with rheumatoid arthritis: an assessor-blinded, randomized crossover study
Secondary ID [1] 291824 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 303064 0
Hand osteoarthritis 303065 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302525 302525 0 0
Other physical medicine / rehabilitation
Inflammatory and Immune System 302526 302526 0 0
Rheumatoid arthritis
Alternative and Complementary Medicine 302527 302527 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kaltenborn 'within-the-slack' Grade I-II manual mobilization is carried out in this study at the Rheumatology Clinic of the Karolinska University Hospital in Solna, Stockholm, Sweden, by five licensed Swedish manual therapists (1 physiotherapist, 4 naprapaths: minimum 1 year of experience) on the metacarpophalangeal (MCP) joints II-V of the hands of participants with rheumatoid arthritis (primary group) or hand osteoarthritis (clinical comparator group). Treatments are carried out individually per participant with two different therapists per hand.

Kaltenborn Grade I-II manual mobilization is a method in manual therapy whereby the treated joint is gently mobilized with a traction force to reduce pain and help the joint regain functionality and flexibility. The method is utilized by manual therapists worldwide -- including physiotherapists, chiropractors, and naprapaths -- for treating joint- and muscle-related pain. In the context of this study, the session would begin with the participant sitting comfortably in front of a treatment table. One hand, relaxed from the support of a mobilization wedge or pillow, would face palm up. The therapist would then grip the proximal and intermediate phalanges of the finger with one hand whilst the other would grip the metacarpus for support; and then the joint (i.e. MCP II) would be mobilized with a gentle traction force. The process would be repeated for MCPs III-V.

There is one treatment session per week with two sessions over two weeks per hand. First, the randomized hand of each participant is treated with 28-minute mobilization (per joint: 3min + 1min rest + 3min, MCP II-V) at baseline (week 1) and week 2. Upon crossover at week 3, the control hand is instead treated at week 3 and 4. An untreated 1-month follow-up after the final treatment (week 4) is carried out to assess outcome measures after a longer period without mobilization treatment.
Intervention code [1] 297936 0
Treatment: Other
Comparator / control treatment
One hand is randomized per participant to receive Kaltenborn Grade I-II manual mobilization from baseline to week 2. The control hand is untreated until week 3, where it is crossed over for treatment.
Control group
Active

Outcomes
Primary outcome [1] 301942 0
Pain by 100mm visual analog scale (VAS) MCP II-V hand pain (composite)
Timepoint [1] 301942 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Primary outcome [2] 301943 0
MCP II-V hand Doppler signal (composite) by musculoskeletal ultrasound
Timepoint [2] 301943 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Primary outcome [3] 301944 0
MCP II-V radiographic joint space (composite) by musculoskeletal ultrasound
Timepoint [3] 301944 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [1] 334305 0
Primary outcome: VAS-hand pain region (MCP II-V + proximal/distal interphalangeal (PIP/DIP) joints II-III) (composite)
Timepoint [1] 334305 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [2] 334306 0
Primary outcome: VAS-pain overall
Timepoint [2] 334306 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [3] 334307 0
Primary outcome: Tender joint count of the hands and wrists, assessed by physicians interacting with the patient and applying pressure on each joint
Timepoint [3] 334307 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [4] 334308 0
Primary outcome: Patient-reported tender joint count of the hands and wrists without applying joint pressure, before physician assessment
Timepoint [4] 334308 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [5] 334309 0
Primary outcome: Swollen joint count of the hands and wrists, assessed by physicians interacting with the patient and applying pressure on each joint
Timepoint [5] 334309 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [6] 334310 0
Primary outcome: Regional hand Doppler signal (MCP II-V + DIP/PIP II-III) by musculoskeletal ultrasound
Timepoint [6] 334310 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [7] 334311 0
Primary outcome: MCP II-V synovial fluid by musculoskeletal ultrasound
Timepoint [7] 334311 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [8] 334575 0
Primary outcome: Regional synovial fluid (MCP II-V + DIP/PIP II-III) by musculoskeletal ultrasound
Timepoint [8] 334575 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [9] 334576 0
Primary outcome: Regional radiographic joint space (MCP II-V + DIP/PIP II-III) by musculoskeletal ultrasound
Timepoint [9] 334576 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [10] 334577 0
VAS-pain MCP I
Timepoint [10] 334577 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [11] 334579 0
VAS overall fatigue
Timepoint [11] 334579 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [12] 334580 0
VAS-global health, participant-reported
Timepoint [12] 334580 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [13] 334581 0
VAS-global health, physician-assessed
Timepoint [13] 334581 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [14] 334582 0
Short form-36 for health-related quality of life
Timepoint [14] 334582 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [15] 334583 0
Health assessment questionnaire (HAQ) for functional disability
Timepoint [15] 334583 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [16] 334584 0
Modified clinical disease activity index (M-CDAI) based on all hand/wrist joints (excluding knees, elbows, and shoulders)
Timepoint [16] 334584 0
Baseline; Week 2, 3, 4; Follow-up (2 months)
Secondary outcome [17] 334585 0
Modified disease activity score (M-DAS28) based on all hand/wrist joints (excluding knees, elbows, and shoulders) (only patients with rheumatoid arthritis)
Timepoint [17] 334585 0
Baseline
Secondary outcome [18] 334586 0
Erythrocyte sedimentation rate (ESR) (only patients with rheumatoid arthritis)
Timepoint [18] 334586 0
Baseline
Secondary outcome [19] 334587 0
C-reactive protein (CRP) (only patients with rheumatoid arthritis)
Timepoint [19] 334587 0
Baseline
Secondary outcome [20] 334588 0
Doppler signal of the radial, midcarpal, and ulnar sections of the wrists (composite) by musculoskeletal ultrasound
Timepoint [20] 334588 0
Baseline; Week 2; Follow-up (2 months)
Secondary outcome [21] 334589 0
Synovial fluid of the radial, midcarpal, and ulnar sections of the wrists (composite) by musculoskeletal ultrasound
Timepoint [21] 334589 0
Baseline; Week 2; Follow-up (2 months)

Eligibility
Key inclusion criteria
Daily bilateral hand pain; diagnosis of rheumatoid arthritis or hand osteoarthritis at least six months prior to inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Chronic bone damage or soft tissue injuries in the hands; acute hand inflammation within the latest week; surgery on the shoulder, arm, or hand within the latest 3 months of any kind; pregnancy within the latest 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised simple randomisation stratified by diagnosis (rheumatoid arthritis or hand osteoarthritis)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This was a pilot study assessing the clinical applicability, safety and effectiveness of mobilization in rheumatoid arthritis, where as many participants would be gathered as possible within a time frame of two years.
Statistical analyses include the Independent Samples Mann-Whitney U test, the Paired Samples Wilcoxon Signed Ranked test, or the Kruskal-Wallis test or Friedman test with Dunn-Bonferroni correction for continuous data. Pearson’s Chi Square or Fisher’s exact test are utilized with proportions. All analyses are performed on IBM SPSS v24.0. Two-tailed p-values <0.050 are considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
27/02/2015
Date of last participant enrolment
Anticipated
Actual
14/12/2016
Date of last data collection
Anticipated
Actual
8/02/2017
Sample size
Target
25
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 8861 0
Sweden
State/province [1] 8861 0
Stockholm

Funding & Sponsors
Funding source category [1] 296324 0
University
Name [1] 296324 0
Karolinska Institutet (Staff salaries, study equipment)
Country [1] 296324 0
Sweden
Funding source category [2] 296388 0
Hospital
Name [2] 296388 0
Karolinska University Hospital (Staff salaries, study equipment)
Country [2] 296388 0
Sweden
Primary sponsor type
Individual
Name
Ronald van Vollenhoven
Address
Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID)
Karolinska Institutet
D1:00, Karolinska University Hospital, Solna
17176 Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 295336 0
None
Name [1] 295336 0
Address [1] 295336 0
Country [1] 295336 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297554 0
EPN, Regionala etikprovningsnamnden i Stockholm
Ethics committee address [1] 297554 0
Regionala etikprovningsnamnden i Stockholm
FE 289
171 77 Stockholm
Sweden
Ethics committee country [1] 297554 0
Sweden
Date submitted for ethics approval [1] 297554 0
21/01/2015
Approval date [1] 297554 0
30/01/2015
Ethics approval number [1] 297554 0
2014/2155-32; 2013/2202-31

Summary
Brief summary
The purpose of this study is to assess the clinical applicability, safety and effectiveness of Kaltenborn manual mobilization of the hands in rheumatoid arthritis through affecting pain, tender/swollen joints, and musculoskeletal ultrasound outcomes; and to compare these findings across the treated and untreated hand; through crossover and follow-up; and through a clinical comparator group with hand osteoarthritis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 74418 0
Prof Ronald van Vollenhoven
Address 74418 0
Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID)
Karolinska Institutet
D1:00, Karolinska University Hospital, Solna
17176 Stockholm
Sweden
Country 74418 0
Sweden
Phone 74418 0
+46 (0)8 517 760 77
Fax 74418 0
Email 74418 0
[email protected]
Contact person for public queries
Name 74419 0
Dr Adrian Levitsky
Address 74419 0
Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID)
Karolinska Institutet
D1:00, Karolinska University Hospital, Solna
17176 Stockholm
Sweden
Country 74419 0
Sweden
Phone 74419 0
+46 (0)8 517 730 65
Fax 74419 0
Email 74419 0
[email protected]
Contact person for scientific queries
Name 74420 0
Dr Adrian Levitsky
Address 74420 0
Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID)
Karolinska Institutet
D1:00, Karolinska University Hospital, Solna
17176 Stockholm
Sweden
Country 74420 0
Sweden
Phone 74420 0
+46 (0)8 517 730 65
Fax 74420 0
Email 74420 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Research participants who were included in the study gave written, informed consent that their data could be used for future analyses (in this case, only within the EU/EEA region). However, there are currently no plans for using this data beyond the original published data due to no planned future collaborations. Until such a time, we will protect the privacy of the individuals by not sharing individual participant data.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Levitsky A, Kisten Y, Lind S, Nordström P, Hulthol... [More Details]
Plain language summaryNo Background: Despite major advances in treating rhe... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseJoint Mobilization of the Hands of Patients With Rheumatoid Arthritis: Results From an Assessor-Blinded, Randomized Crossover Trial.2019https://dx.doi.org/10.1016/j.jmpt.2018.04.007
N.B. These documents automatically identified may not have been verified by the study sponsor.