A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome
NCT ID: NCT05306548
Last Updated: 2025-08-28
Study Results
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Basic Information
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RECRUITING
PHASE4
258 participants
INTERVENTIONAL
2022-04-08
2028-03-31
Brief Summary
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Detailed Description
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Currently, many patients with mild and moderate CTS treated surgically without a preceding trial of less invasive non-surgical therapies. An increase in the use of non-surgical first-line therapies (e.g. corticosteroid injection into the carpal tunnel), while reserving surgery for refractory cases, aim to optimize the trade-off between treatment risk and benefit, while also ensuring appropriate use of health resources. However, there is a lack of studies directly comparing the efficacy of corticosteroid injections to surgery, and the long-term safety of corticosteroid injections has not been investigated.
It is not well-known if patients who are initially treated with corticosteroid injections will eventually need to proceed to surgery, and therefore may have to endure the symptoms for a longer period of time, with potentially worse long-term outcomes, compared to patients who has surgery as first-line treatment. On the other hand, it is not beneficial if patients are unnecessarily exposed to the risks associated with surgery, if symptoms could have been satisfactory resolved with a non-surgical method.
The current study will assess if first-line treatment with up to two ultrasound-guided corticosteroid injections is non-inferior to surgery with regards to treatment success. A less invasive treatment approach might result in important benefits to the patient, e.g. less pain, reduced risk of complications, and faster return to work and activities. This might also be of importance to family members, as many CTS patients are at an age where they have care responsibilities. Non-surgical treatments might benefit society by decreasing work absence and reducing health expenditure, and allowing better access to surgical services for other patient groups. High quality documentation is needed to provide a base for future treatment guidelines. Evidence based clinical guidelines provide treatment decision support and help reduce national and regional differences in treatment practices, and ensure that all patients have equal access to evidence-based treatment.
In the NOR-CACTUS trial, adult individuals with idiopathic CTS of a mild-to-moderate degree will be randomized to receive either A) Primary open surgical carpal tunnel release, or B) Up to two ultrasound-guided corticosteroid (triamcinolone hexacetonide) injections in the carpal tunnel, and subsequent open surgical carpal tunnel release in case of unsatisfactory treatment result. Participants will be randomized to receive one of the treatment strategies, and followed for two years, with the primary endpoint being successful treatment result one year after start of the intervention.
The hypothesis of the study is that the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention in the injection treatment strategy arm is non-inferior to that of the surgery treatment arm. The primary outcome is based on the disease-specific patient-reported outcome Boston Carpal Tunnel Questionnaire (BCTQ) symptom severity scale (SSS). Further outcomes will include other patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Surgery treatment strategy
Primary open surgical carpal tunnel release. Treatment effect is monitored on scheduled follow-up visits. Re-operation may be performed if medically indicated (e.g. postoperative complication, or failure of the primary procedure)
Surgical carpal tunnel release
Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve
Injection treatment strategy
Primary treatment with ultrasound-guided corticosteroid injection. Treatment effect is monitored on scheduled follow-up visits. One additional injection may be administered, and subsequently surgical carpal tunnel release is performed in case of unsatisfactory treatment effect of the injection therapy. Treatment effect is graded on a 5-leve scale by subject from 1 (complete improvement) to 5 (severe worsening) of symptoms. Incomplete improvement (score 2 or higher) results in a second injection or secondary surgery.
Surgical carpal tunnel release
Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve
Injection, Triamcinolone Hexacetonide, Per 5 Mg
Ultrasound-guided injection of 20 mg of triamcinolone hexacetonide (or -acetonide) into the carpal tunnel space close to the median nerve
Interventions
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Surgical carpal tunnel release
Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve
Injection, Triamcinolone Hexacetonide, Per 5 Mg
Ultrasound-guided injection of 20 mg of triamcinolone hexacetonide (or -acetonide) into the carpal tunnel space close to the median nerve
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient history indicating CTS
3. Neurophysiological examination performed within 6 months
4. Diagnosis of CTS based on:
1. Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS
Or, in case of normal neurophysiological findings:
2. Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms
5. Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)
Exclusion Criteria
2. Diagnosis of severe CTS, based on history and examination indicating severe CTS with constant symptoms including pain, loss of sensibility, dexterity or reduced temperature sensation, weakness of thumb abduction and opposition, or atrophy of thenar musculature. Disappearance of pain may indicate permanent sensory loss.
3. History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
4. Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
5. Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
6. Major co-morbidities, such as severe malignancies, severe or uncontrolled infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV) and/or severe respiratory diseases, severe renal failure, active ulcus ventriculi, leukopenia and/or thrombocytopenia
7. Severe psychiatric or mental disorders
8. Local infection or wound in the affected hand/wrist
9. Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible
10. Inadequate birth control1, pregnancy2, and/or breastfeeding (current at screening or planned within the duration of the study)
11. Known hypersensitivity to Triamcinolone Hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol)
12. Concomitant therapy with CYP3A-inhibitors or digitalis glycosides
13. Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment
14. Alcohol or other substance abuse
15. Language barriers
16. Other factors which make adherence to study protocol impossible
18 Years
ALL
No
Sponsors
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Oslo University Hospital
OTHER
Martina Hansen's Hospital
OTHER
South-Eastern Norway Regional Health Authority
OTHER
University Hospital, Akershus
OTHER
Diakonhjemmet Hospital
OTHER
Responsible Party
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Hilde Berner Hammer
Principal Investigator
Principal Investigators
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Hilde B Hammer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Diakonhjemmet Hospital
Locations
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Akershus University Hospital
Lørenskog, Akershus, Norway
Department of Surgery and Anesthesiology, Diakonhjemmet Hospital
Oslo, Norge, Norway
Department of Rheumatology, Diakonhjemmet Hospital
Oslo, , Norway
Department of Orthopedic Surgery, Martina Hansens Hospital
Sandvika, , Norway
Department of Rheumatology, Martina Hansens Hospital
Sandvika, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Bland JD. A neurophysiological grading scale for carpal tunnel syndrome. Muscle Nerve. 2000 Aug;23(8):1280-3. doi: 10.1002/1097-4598(200008)23:83.0.co;2-y.
Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
Beaton DE, Wright JG, Katz JN; Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am. 2005 May;87(5):1038-46. doi: 10.2106/JBJS.D.02060.
Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
Other Identifiers
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DIA2021-8
Identifier Type: -
Identifier Source: org_study_id
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