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

NCT ID: NCT06769373

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-06-15

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.

Detailed Description

Distal radius fractures are the most common fracture type among all body bone fractures. Fractures generally occur in elderly patients caused by low-energy trauma due to decreased bone quality. In young patients, they mostly occur due to traumas such as traffic accidents, falls from heights and sports injuries.

One of the important complications seen after distal radius fractures is complex regional pain syndrome (CRPS). Complex regional pain syndrome represents a complication following distal radius fractures that is still not fully understood etiologically.

Studies have shown that complex regional pain syndrome is commonly diagnosed among patients recovering from a fracture of the distal radius with a reported incidence as high as 37%. It is characterized by excessive pain (allodynia and/or hyperalgesia), edema, local blood flow changes and abnormality of the sudomotor nerve.

There are hardly any studies with a sufficient evidence level to make recommendations for treatments for CRPS-1; therefore, treatment is based on symptom management. Prevention of CRPS-1, after a distal radius fracture is important as this syndrome might lead to chronic pain and serious disabilities. In several studies, it was shown that CRPS-1 can be cured with exercise and graded activities. The main goals of physiotherapy are to reduce pain, regain range of motion, and increase muscle strength and function.

Whirlpool bath and contrast bath treatments are physical therapy methods that has been used safely in complex regional pain syndrome treatment for many years.

Whirlpool baths are local baths where the extremities are immersed in rapidly circulating water. The swirling water produced by the whirlpool bath creates a massaging effect on the body, which can help relieve muscle tension and alleviate pain. The combination of warm water and hydrostatic pressure can also enhance blood circulation and improve joint mobility.

Contrast baths constitute a thermal modality whereby the hand is alternately immersed in hot and cold water for a specified temperature, time, and duration to therapeutically decrease edema, stiffness, pain and increase functionality in cases of complex regional pain syndrome after fractures.

Our primary aim is to investigate the effects of whirlpool bath and contrast bath treatments on pain, disability, functionality and grip strength in patients who were followed conservatively with complex regional pain syndrome (CRPS-1) after distal radius fracture.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Whirlpool Bath Protocol

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.

Group Type: EXPERIMENTAL

Whirlpool Bath

Intervention Type: 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.

Contrast Bath Protocol

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.

Group Type: EXPERIMENTAL

Contrast Bath

Intervention Type: 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.

Interventions

Whirlpool Bath

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.

Intervention Type: DEVICE

Contrast Bath

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Afyonkarahisar Health Sciences University

OTHER

Sponsor Role: lead

Responsible Party

Duygu Keskin

Research Assistant Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Afyonkarahisar Health Sciences University

Afyonkarahisar, Afyonkarahisar, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ersin Beştaş, MD

Role: CONTACT

ersinbestas26@gmail.com

+905068893266

Duygu Keskin, research assistant

Role: CONTACT

keskiin01@hotmail.com

+905077902716

Facility Contacts

Ersin Beştaş, MD

Role: primary

ersinbestas26@gmail.com

+905068893266

Duygu Keskin, MD

Role: backup

keskiin01@hotmail.com

+905077902716

References

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.

Reference Type: BACKGROUND

PMID: 31916452 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24080349 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28453348 (View on PubMed)

Other Identifiers

DK2025

Identifier Type: -

Identifier Source: org_study_id