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Local Steroid Injection vs Placebo in Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02652390
Recruitment Status : Completed
First Posted : January 11, 2016
Results First Posted : October 22, 2018
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Isam Atroshi, Region Skane

Brief Summary:
Between 2008 and 2012 the investigators performed a single-center randomized double-blind placebo-controlled trial to assess the efficacy of local injection of two different doses of methylprednisolone (80 mg and 40 mg) in patients with carpal tunnel syndrome (CTS), aged 18 to 70 years, not previously treated with steroid injection. The primary outcomes were change in the CTS symptom severity score at 10 weeks and rate of carpal tunnel release surgery on the study hand at 1 year. In the trial 111 patients were randomized (37 in each of the 3 groups: 80 mg methylprednisolone, 40 mg methylprednisolone and placebo) and all completed the 1-year follow-up. The investiators plan an extended follow-up 5 to 7 years after injection.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: Methylprednisolone 80 mg Drug: Methylprednisolone 40 mg Other: Saline Phase 4

Detailed Description:

Extended follow-up protocol:

All 111 trial participants will be contacted by telephone by a researcher and given information about this extended follow-up. A questionnaire together with written information and consent forms will be sent by mail. The questionnaire consists of the CTS symptom severity sale, 11-item DASH scale, bodily pain scale, and a treatment satisfaction visual analog scale (VAS), that were used in previous follow-up evaluations. The questionnaire will also include the 6-item CTS symptoms scale (CTS-6) and the palmar pain scale. The patients will be asked whether and when they had undergone carpal tunnel release surgery on the study hand after they received the injection within the trial. Patients' records will be reviewed to verify data about subsequent surgery on the study hand.

The Chi-square test will be used to compare the 80-mg methylprednisolone group and the placebo group with regard to the proportion of patients who have had carpal tunnel release surgery on the study hand within 5 years after injection (primary outcome). The change in symptom severity score in patients in the 80-mg methylprednisolone group who did not have surgery on the study hand after injection will be compared with the change in symptom severity score in patients who had surgery on the study hand after methylprednisolone injection (co-primary outcome) using analysis of covariance (ANCOVA) adjusting for sex, age, dominance of the study hand and baseline symptom severity score. A similar comparison will be made for the 11-item DASH and the bodily pain scores. The palmar pain score at 5 to 7 years will be compared between the groups using the independent-samples t-test and also ANCOVA to adjust for sex, age and dominance of the study hand. Patients who had surgery after methylprednisolone injection will be compared with patients who had surgery after placebo injection with regard to change from baseline to 5 to 7 years in the symptom severity score, 11-item DASH scale score, bodily pain score and satisfaction score using ANCOVA adjusting for sex, age, dominance of the study hand and respective baseline score. To identify potential predictive factors for long-term benefit after 80 mg methylprednisolone injection, surgery within 5 years will be analyzed according to the variables sex, age, dominance of the study hand, baseline symptom severity score (≥3 versus < 3) and baseline median nerve conduction abnormality (severe/moderate vs mild/normal).

All statistical tests will be 2-sided and a p value of less than 0.05 will indicate statistical significance.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Extended Follow-up of a Randomized Placebo-controlled Trial of Local Steroid Injection in Carpal Tunnel Syndrome
Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016


Arm Intervention/treatment
Experimental: Methylprednisolone 80 mg
Local injection of 80 mg Methylprednisolone into the carpal tunnel
Drug: Methylprednisolone 80 mg
2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
Other Name: Depo-Medrol

Experimental: Methylprednisolone 40 mg
Local injection of 40 mg Methylprednisolone into the carpal tunnel
Drug: Methylprednisolone 40 mg
1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
Other Name: Depo-Medrol

Placebo Comparator: Placebo
Local injection of saline into the carpal tunnel
Other: Saline
2 mL saline + 1 mL lidocaine
Other Name: Sodium chloride solution




Primary Outcome Measures :
  1. Number of Patients Who Have Had Carpal Tunnel Release Surgery on the Study Hand [ Time Frame: 5 to 7 years ]
    Number of patients who have had carpal tunnel release surgery on the study hand.

  2. Symptom Severity Score [ Time Frame: 5-7 years ]
    Change in symptom severity score from baseline to 5 to 7 years. Score range 1 (no symptoms) to 5 (most severe symptoms).


Secondary Outcome Measures :
  1. Palmar Pain Score [ Time Frame: 5-7 years ]
    Score for pain in the proximal palm and related activity limitations, range 0 (worst) to 100 (best).

  2. 11-item Disabilities of the Arm, Shoulder and Hand (DASH) Score [ Time Frame: 5-7 years ]
    Score for the 11-item DASH scale, a measure of activity limitations related to the upper extremity. Score range 0 (best) to 100 (worst)

  3. Bodily Pain Score [ Time Frame: 5-7 years ]
    Score for the 2-item bodily pain scale, range 0 (worst) to 100 (best).

  4. Satisfaction Score [ Time Frame: 5-7 years ]
    Visual analog scale about treatment satisfaction, score 0 (worst) to 100 (best).



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary idiopathic CTS
  • Symptoms of classic or probable CTS according to the Katz diagnostic criteria (numbness and/or tingling in at least 2 of the 4 median nerve innervated fingers)
  • Failed treatment with wrist splinting (2 months)
  • Nerve conduction tests showing median neuropathy at the wrist or, if normal, two orthopedic surgeons independently make CTS diagnosis
  • Symptom severity that warranted referral for consideration for surgery

Exclusion Criteria:

  • Previous steroid injection for CTS
  • Thenar muscle atrophy
  • Sensory deficit (two-point discrimination >8 mm)
  • Diabetes, thyroid disorder, or inflammatory disease
  • Polyneuropathy or vibration-induced neuropathy
  • Current pregnancy
  • Previous carpal tunnel surgery on the study hand
  • Surgery on the contralateral hand in the past 2 months
  • Inability to respond to questionnaires
  • Severe medical illness
  • Known drug/alcohol abuse

Publications of Results:
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Responsible Party: Isam Atroshi, Professor, Region Skane
ClinicalTrials.gov Identifier: NCT02652390     History of Changes
Other Study ID Numbers: HLM_CTS_2
First Posted: January 11, 2016    Key Record Dates
Results First Posted: October 22, 2018
Last Update Posted: October 22, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents