Efficacy Study of Local Steroid Injection and Wrist Splinting for Carpal Tunnel Syndrome

NCT02140632 | Completed Phase 4

• 1 other identifier: FR-13-018(64-16)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Carpal tunnel syndrome is caused by the compression of median nerve at the wrist where it passes through a narrow space called carpal tunnel formed by the wrist bones, ligaments and tendons. The common symptoms include numbness and pain over the areas supplied by the median nerve namely the thumb, the index finger, the middle finger and the outer part of the ring finger. There can be loss of sensation, weakness or muscle atrophy in severe cases. The functions of the affected hands may be greatly impaired. Carpal tunnel syndrome is very common. It can lead to significant economic impact both to the affected individual and the society either by the direct treatment cost and indirectly from the working ability loss. Despite the vast burden, there is no consensus regarding its treatment so far. Surgery is generally effective and often reserved for severe cases. There are many nonsurgical treatment options. Local steroid injection and wrist splinting are among the commonest and with more evidence. Local steroid injection into the carpal tunnel can reduce the inflammation and swelling. Wrist splinting can maintain the wrist at its neutral position where the pressure at the carpal tunnel is the least. However, there are only very few studies comparing these two treatments directly. Patients complaining of finger numbness who have been confirmed to have carpal tunnel syndrome by nerve conduction test are invited to participate in the study. The patients who agreed to be recruited are asked about their basic informations and the details of the carpal tunnel syndrome symptoms. Their hands will be examined. They are asked to fill in a questionnaire specific for assessing the symptom severity and the functional status of patients with carpal tunnel syndrome. They will then be assigned to one of the two treatment groups randomly and receive the respective treatment. They need to come back for follow-up at one month and to fill in the questionnaire again. The study hypothesis is local steroid injection is more effective than wrist splinting in treating carpal tunnel syndrome.

Conditions

Carpal Tunnel Syndrome; Local Steroid Injection; Wrist Splinting

Keywords

Carpal tunnel syndrome; Local steroid injection; Wrist splinting

Outcome Measures

Primary Outcomes (1)

• Clinical improvement at one month

  The Boston Carpal Tunnel Questionnaire is used as the measure assessing clinical response. It is a self-administered disease-specific questionnaire for assessing severity of symptoms and functional status based on two scales. The symptom severity scale is comprised of 11 questions, and the functional status scale is comprised of 8 questions. The assessment of each question is on a scale of 1-5 points, in which 1 indicates no symptom, and 5 indicates severe symptoms. Each scale generates a final score (sum of individual scores divided by number of items) which ranges from 1 to 5.

  One month after treatment

Secondary Outcomes (7)

• Patient satisfaction at one month

  One month after treatment

• Side effects

  One month after treatment

• Prognostic factor - Age

  One month after treatment

• Prognostic factor - Gender

  One month after treatment

• Prognostic factor - Duration of symptoms

  One month after treatment

Study Arms (2)

Local steroid injection

EXPERIMENTAL

The local injection of steroid is performed by the same investigator after the randomization. Using a sterile technique, 20mg methylprednisolone acetate premixed with lidnocaine is injected using a 25-gauge x 5/8" needle. The needle is inserted medially to the palmaris longus tendon at the distal palmar crease in the wrist at an angle of 45-degree to the forearm. The steroid is injected at approximately 1cm below the skin. The needle will be repositioned if there is any resistance to injection, or any pain or paraesthesia in the median nerve territory.

Procedure: Local methylprednisolone acetate and lidnocaine injection

Wrist splinting

ACTIVE COMPARATOR

After randomization, the hands of the patients in the splinting group are splinted in neutral position with standard cotton-polyester splint. Patients are encouraged to use the splints during nighttime whenever possible for one month.

Device: wrist splinting

Interventions

Local methylprednisolone acetate and lidnocaine injection PROCEDURE

Also known as: depomedrol with lidnocaine

Local steroid injection

wrist splinting DEVICE

Wrist splinting

Eligibility Criteria

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

You may qualify if:

• patients attending the medical clinic of Kwong Wah Hospital with clinical and electrophysiological features of CTS

You may not qualify if:

• any recognized causes of CTS including inflammatory arthritis, diabetes mellitus, hypothyroidism, renal failure, polyneuropathy and history of significant local trauma
• previous treatment of CTS
• pregnancy
• patients with motor impairment or thenar muscle atrophy

Sponsors & Collaborators

• Kwong Wah Hospital: lead

Study Sites (1)

Kwong Wah Hospital

Kowloon, Hong Kong, China

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Ho So, MBBS

  Kwong Wah Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident specialist

Study Record Dates

• First Submitted: May 10, 2014
• First Posted: May 16, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 1, 2016

Record last verified: 2016-08

Locations

CN (1)