RecruitingACTRN12619000886189

Non-operative management of TFCC injury; a randomised, control trial investigating hand therapy, wrist splint and cortisone injection for triangular fibrocartilage complex injuries in the wrist

The impact of hand therapy, volar wrist splinting and corticosteroid injection, on pain and function outcomes of triangular fibrocartilage complex injuries in adults


Sponsor

Brisbane Hand & Upper Limb Research Institute

Enrollment

180 participants

Start Date

Jul 30, 2019

Study Type

Interventional

Conditions

Summary

This study aims to determine the effectiveness and clinical outcomes of non-operative treatments offered to patients who have a triangular fibrocartilage complex (TFCC) injuries. Injury to the triangular fibrocartilage complex has been observed as a common cause of both short and long-term wrist pain, loss of wrist function and impact on quality of life. Currently, it is common practice for health care providers to initially recommend non-surgical or “conservative treatments” for patients. Treatments can include immobilising the wrist using a splint to relieve pain; injection of corticosteroid to reduce inflammation and provide pain relief; and hand therapy exercises to help manage pain and improve function. This study will investigate whether splint immobilisation, corticosteroid injection or a combination of the two, contribute to the efficacy of hand therapy, in relieving symptoms and improving function in patients with TFCC tears. Adults presenting with a MRI confirmed TFCC tear, between 6 weeks and 12 months from primary injury will be invited to participate in the research study. Participants will be randomly allocated to one of four groups: Group A: will receive hand therapy Group B: will receive a thermoplastic, volar wrist splint + hand therapy Group C: will receive a corticosteroid injection to the wrist + hand therapy Group D: will receive a wrist splint + corticosteroid injection + hand therapy. Participants will be asked to complete an electronic survey consisting questions specific to wrist pain and function. The survey will be completed in-person before treatment and at 6 weeks and 12 weeks after intervention commencement. The investigation will be conducted at the Brisbane Hand and Upper Limb Research Institute at the Brisbane Private Hospital.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

The triangular fibrocartilage complex (TFCC) is a structure inside the wrist that acts as a shock absorber and helps stabilise the joint during rotation. Injuries to the TFCC are a common cause of persistent wrist pain and reduced grip strength, often affecting people for many months after the original injury. While surgery is sometimes needed, most patients are first treated conservatively — but doctors and therapists are unsure which non-surgical approach works best. This study compares four non-surgical treatment options for adults with a confirmed TFCC tear (confirmed by MRI scan): hand therapy alone, hand therapy plus a wrist splint, hand therapy plus a cortisone injection, or all three together. Participants will be randomly assigned to one of these four groups and followed for 12 weeks, completing questionnaires about wrist pain and function at the start and at 6 and 12 weeks. Adults presenting within 6 weeks to 12 months of a wrist injury, with a confirmed isolated TFCC tear and ulnar-sided wrist pain, are eligible. People with instability of the wrist joint, arthritis, other injuries alongside the TFCC tear, or allergies to cortisone or local anaesthetic are not eligible. This research could establish a clear, evidence-based first-line treatment for one of the most common — and currently under-researched — wrist injuries.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

Participants will be randomly assigned to one of four treatment groups: Group A: will receive hand therapy Group B: will receive a thermoplastic, volar wrist splint + hand therapy Group C: will rec

Participants will be randomly assigned to one of four treatment groups: Group A: will receive hand therapy Group B: will receive a thermoplastic, volar wrist splint + hand therapy Group C: will receive a corticosteroid injection to the wrist + hand therapy Group D: will receive a wrist splint + corticosteroid injection + hand therapy All procedures and appointments will be based in Brisbane, Queensland. Hand therapy (all participants) Participants will have a 30 minute therapy session with a qualified hand therapist at baseline and two 15 minute sessions, at 2 and 6 weeks post baseline. The hand therapist will use a therapy protocol designed by study investigators to deliver advice on protecting the wrist using activity modification and instruct the participant on an exercise regime to follow at home. All participants, irrespective of treatment randomisation, will be provided with the same Hand Therapy Protocol booklet to follow at home. Participants will be encouraged to use the support of their unaffected wrist when performing activities that may otherwise aggravate symptoms of the injured wrist. The protocol is divided into three phases, to be provided to participants in installments at each therapy appointment. A 2kg and 0.5kg vinyl dumbbell will be provided to participants at the baseline and 2 week appointment for the completion of exercises at home. Phase one, delivered at baseline, involves daily active range of motion exercises and bicep curls using a 2kg weight. Phase two, initiated at 2 weeks post baseline, incorporates the addition of resistance exercises. All prescribed exercises from the first phase will continue, with the addition of an isometric ECU exercise and resisted pronation with a 0.5kg dumbbell. Phase three, commencing 6 weeks post baseline, includes further strengthening exercises and gentle loading to the wrist. The 0.5kg weight will be used to perform resisted ulnar deviation and controlled wall push-ups will be included in the home exercise regime from 6 weeks, in addition to the exercises prescribed in the first two phases. Compliance to the exercise regime over the 12-week treatment period will be recorded on a patient-reported exercise log provided to all participants. Thermoplastic, volar wrist splint (Treatment arms B and D) At the baseline therapy appointment, the therapist will fit a custom thermoplastic, volar wrist splint. As two therapy clinics will be administering treatment, a standardised design protocol designed by study investigators will be distributed to ensure consistency between therapists and clinics. The splint design will be a short-arm, volar thermoplastic splint. The splint will be approximately two thirds of the length of the patients forearm and cover half of the circumference on the volar/palmer side of the wrist. Care will be taken to ensure that the ulnar styloid is not covered, the thumb is free to allow full opposition and that range of movement of the MCP joints are not restricted. Velcro straps will be used to secure the splint and a tubigrip sleeve will be worn underneath for comfort. Participants will be instructed to wear the splint during the day for 6 weeks, before reducing to symptomatic use only for 2 weeks. Corticosteroid injection (Treatment arms C and D) On the day of the 6 week treatment appointment following hand therapy the participant will be referred to a radiologist who will administer a corticosteroid injection to the wrist. A 1 mL betamethasone sodium phosphate/betamethasone acetate injection with 0.5% bupivacaine hydrochloride will be injected under direct ultrasound guidance to the triangular fibrocartilage complex of the wrist. Symptomatic and functional progress in addition to compliance to treatment protocols will be monitored using patient-reported questionnaires administered in-person at baseline, 6 weeks and 12 weeks. The questionnaire will be administered by a research assistant at individual participant appointments.


Locations(1)

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12619000886189


Related Trials