Efficacy Study of Local Steroid Injection and Wrist Splinting for Carpal Tunnel Syndrome
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|ClinicalTrials.gov Identifier: NCT02140632|
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : September 1, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Carpal Tunnel Syndrome Local Steroid Injection Wrist Splinting||Procedure: Local methylprednisolone acetate and lidnocaine injection Device: wrist splinting||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Local Steroid Injection vs Wrist Splinting for Carpal Tunnel Syndrome: A Randomized Clinical Trial|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Local steroid injection
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
Other Name: depomedrol with lidnocaine
Active Comparator: Wrist splinting
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
- Clinical improvement at one month [ Time Frame: One month after treatment ]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.
- Patient satisfaction at one month [ Time Frame: One month after treatment ]Assessment of patient satisfaction is classified on a 5-point scale as completely satisfied, almost satisfied, moderately satisfied, somewhat satisfied, and dissatisfied.
- Side effects [ Time Frame: One month after treatment ]Any side effects thought to be related to the interventions are documented.
- Prognostic factor - Age [ Time Frame: One month after treatment ]The association between age and the response to treatment (symptom severity scale and functional status scale) is assessed.
- Prognostic factor - Gender [ Time Frame: One month after treatment ]The association between gender and the response to treatment (symptom severity scale and functional status scale) is assessed.
- Prognostic factor - Duration of symptoms [ Time Frame: One month after treatment ]The association between the duration of symptoms and the response to treatment (symptom severity scale and functional status scale) is assessed.
- Prognostic factor - Presence or absence of sensory deficit [ Time Frame: One month after treatment ]The association between the presence or absence of sensory deficit and the response to treatment (symptom severity scale and functional status scale) is assessed.
- Prognostic factor - Nerve conduction velocity severity [ Time Frame: One month after treatment ]The association between the nerve conduction velocity severity (1-3) and the response to treatment (symptom severity scale and functional status scale) is assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140632
|China, Hong Kong|
|Kwong Wah Hospital|
|Kowloon, Hong Kong, China|
|Principal Investigator:||Ho So, MBBS||Kwong Wah Hospital|