The Effects of Whirlpool and Contrast Bath in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture

NCT06769373 | Recruiting

• 1 other identifier: DK2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients with complex regional pain syndrome after distal radius fracture.

Conditions

Distal Radius Fracture; Complex Regional Pain Syndrome Type I; Complex Regional Pain Syndrome

Keywords

Whirlpool; Contrast bath; hydrotherapy

Outcome Measures

Primary Outcomes (2)

• Range of Motion Measurement

  Supination and pronation of the forearm, flexion, extension, ulnar and radial deviation active/passive range of motion of the wrist will be evaluated with a universal goniometer. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.

  up to 12th week

• Hand grip strength measurement with Jamar Dynamometer

  Jamar Dynamometer measures isometric grip force and strength. Measurements will be made by sitting with the shoulder adducted and neutrally rotated, adjacent to the body, elbow flexed at 90 degrees, wrist dorsiflexed at 0-30 degrees and ulnar deviation at 0-15 degrees with the thumb pointing up. Measurements will be repeated three times, 5 seconds apart, on the hand on the affected side, and the average of the three measurements will be recorded in kilograms. Patients will be examined three times in total: before treatment, after treatment (4th week) and at 12th week.

  up to 12th week

Secondary Outcomes (5)

• Jebsen Taylor Hand Function Test

  up to 12th week

• The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH)

  up to 12th week

• Patient-rated Wrist Evaluation Form

  up to 12th week

• Short Form 36 (SF-36)

  up to 12th week

• Visual Analog Scale (VAS)

  Up to 12th week

Study Arms (2)

Whirlpool Bath Protocol

EXPERIMENTAL

An exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, whirlpool bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks.

Device: Whirlpool Bath

Contrast Bath Protocol

EXPERIMENTAL

An exercise program consisting of hand-wrist range of motion exercises, stretching, strengthening exercises, contrasth bath therapy and transcutaneous electrical nerve stimulation (TENS) is planned for 4 weeks.

Device: Contrast Bath

Interventions

Whirlpool Bath DEVICE

This group of participants will receive an exercise program consisting of 40 minutes hand-wrist range of motion exercises (passive, active assistive), stretching, strengthening exercises, whirlpool bath (32-38 °C) 20 minutes in total, transcutaneous electrical nerve stimulation (TENS) 20 minutes in total for 4 weeks. 5 sessions per week for 20 sessions in the Physical Therapy department.

Whirlpool Bath Protocol

Contrast Bath DEVICE

This group of participants will recieve an exercise program consisting of 40 minutes hand-wrist range of motion exercises (passive, active assistive), stretching, strengthening exercises, contrast bath therapy which consist of 4 minutes hot water (38°C) followed by 1 minute cold water (10°C) periods for 20 minutes in total, transcutaneous electrical nerve stimulation (TENS) 20 minutes in total for 4 weeks. 5 sessions per week for 20 sessions in the Physical Therapy department.

Contrast Bath Protocol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with complex regional pain syndrome type-1 (CRPS-type 1) after distal radius fracture, who were followed conservatively (long/short arm splint-cast) between the ages of 18-70, who applied to AFSU Physical Medicine and Rehabilitation Clinic. It is planned to use the Budapest diagnostic criteria for the diagnosis of CRPS Type 1.

You may not qualify if:

• Orthopedic injuries (other accompanying orthopedic fractures, such as ulna fracture, carpal bone fractures),
• Other system injuries,
• Patients whose distal radius fractures were surgically treated,
• Patients who had previously undergone surgery on the same upper extremity,
• Nerve, tendon and artery injuries accompanying the fracture,
• Other neurological, orthopedic or rheumatological problems affecting the same upper extremity,
• Serious cardiovascular disease,
• Presence of active infection, active dermatitis, skin diseases such as pemphigus, febrile diseases,
• Presence of a fixed catheter in the area,
• Impaired temperature sensationin in the area.

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Boersma EZ, Meent HV, Klomp FP, Frolke JM, Nijhuis-van der Sanden MWG, Edwards MJR. Treatment of Distal Radius Fracture: Does Early Activity Postinjury Lead to a Lower Incidence of Complex Regional Pain Syndrome? Hand (N Y). 2022 Jan;17(1):119-127. doi: 10.1177/1558944719895782. Epub 2020 Jan 9.

  PMID: 31916452 BACKGROUND

• Jellad A, Salah S, Ben Salah Frih Z. Complex regional pain syndrome type I: incidence and risk factors in patients with fracture of the distal radius. Arch Phys Med Rehabil. 2014 Mar;95(3):487-92. doi: 10.1016/j.apmr.2013.09.012. Epub 2013 Sep 29.

  PMID: 24080349 BACKGROUND

• Szekeres M, MacDermid JC, Birmingham T, Grewal R, Lalone E. The Effect of Therapeutic Whirlpool and Hot Packs on Hand Volume During Rehabilitation After Distal Radius Fracture: A Blinded Randomized Controlled Trial. Hand (N Y). 2017 May;12(3):265-271. doi: 10.1177/1558944716661992. Epub 2016 Aug 2.

  PMID: 28453348 BACKGROUND

MeSH Terms

Conditions

Wrist Fractures; Complex Regional Pain Syndromes

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Central Study Contacts

Ersin Beştaş, MD

CONTACT

+905068893266; ersinbestas26@gmail.com

Duygu Keskin, research assistant

CONTACT

+905077902716; keskiin01@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blinded Prospective Randomized Trial
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor

Model Details: Effects of Whirlpool Bath and Contrast Bath Treatments on Pain, Disability, Functionality and Grip Strength in Patients with Complex Regional Pain Syndrome After Distal Radius Fracture. Double-Blinded Prospective Randomized Trial.

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: January 31, 2025
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)