Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 22 for:    "Nerve Compression Syndrome" | "Hormones"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02140632
Recruitment Status : Completed
First Posted : May 16, 2014
Last Update Posted : September 1, 2016
Sponsor:
Information provided by (Responsible Party):
Ho SO, Kwong Wah Hospital

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.


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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Side effects [ Time Frame: One month after treatment ]
    Any side effects thought to be related to the interventions are documented.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
Layout table for location information
China, Hong Kong
Kwong Wah Hospital
Kowloon, Hong Kong, China
Sponsors and Collaborators
Kwong Wah Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ho So, MBBS Kwong Wah Hospital

Layout table for additonal information
Responsible Party: Ho SO, Resident specialist, Kwong Wah Hospital
ClinicalTrials.gov Identifier: NCT02140632     History of Changes
Other Study ID Numbers: FR-13-018(64-16)
First Posted: May 16, 2014    Key Record Dates
Last Update Posted: September 1, 2016
Last Verified: August 2016
Keywords provided by Ho SO, Kwong Wah Hospital:
Carpal tunnel syndrome
Local steroid injection
Wrist splinting
Additional relevant MeSH terms:
Layout table for MeSH terms
Nerve Compression Syndromes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Neuroprotective Agents