A Norwegian Trial Comparing Treatment Strategies for Carpal Tunnel Syndrome

NCT05306548 | Active Not Recruiting Phase 4

• 1 other identifier: DIA2021-8
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 5

Brief Summary

Carpal tunnel syndrome (CTS) causes numbness and pain in the hand and arm, and is an important cause of work absence and disability. The aim of the NOR-CACTUS Trial is to compare outcomes of a treatment strategy where the initial treatment is up to two ultrasound-guided corticosteroid injections, followed by scheduled clinical assessment of treatment effect, and subsequent surgery if needed, to a treatment strategy where surgery is the first-line treatment. Participants will be randomized to one of the treatment strategies, and followed up for two years after start of the study intervention. Outcomes will include patient-reported, clinical, functional and neurophysiological measures, and health-economic aspects. The hypothesis of the study is that there is no difference between the two treatment groups in the percentage of patients with a satisfactory symptom relief (treatment success) one year after the initial therapeutic intervention.

Conditions

Carpal Tunnel Syndrome

Keywords

Surgery; Corticosteroid injection; Ultrasound guided intervention; Nerve conduction studies; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Successful treatment result after 12 months

  Boston Carpal Tunnel Questionnaire Symptom Severity Scale ≤ 1.5 after 12 months Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ SSS, Levine et. al 1993) is a disease-specific patient-reported outcome for CTS-related symptom severity. 11 items are scored by the patient on an ordinal scale from 1 (best) to 5 (worst), providing a mean score ranged 1-5. The primary outcome measure is achievement of BCTQ SSS ≤ 1.5, interpreted as a successful treatment result, 12 months after start of the study intervention.

  12 months

Secondary Outcomes (44)

• Successful treatment result after 3 months

  3 months

• Successful treatment result after 6 months

  6 months

• Successful treatment result after 24 months

  24 months

• Boston Carpal Tunnel Questionnaire Symptom Severity Scale

  0-24 months

• Boston Carpal Tunnel Questionnaire Functional Status Scale

  0-24 months

Other Outcomes (5)

• Use of hospital services

  0-24 months

• Use of primary care resources

  0-24 months

• Work participation

  0-24 months

Study Arms (2)

Surgery treatment strategy

ACTIVE COMPARATOR

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)

Procedure: Surgical carpal tunnel release

Injection treatment strategy

EXPERIMENTAL

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.

Procedure: Surgical carpal tunnel release; Drug: Injection, Triamcinolone Hexacetonide, Per 5 Mg

Interventions

Surgical carpal tunnel release PROCEDURE

Open surgical division of the flexor retinaculum of the palm/wrist to release pressure on the median nerve

Also known as: Open surgical carpal tunnel release

Injection treatment strategy; Surgery treatment strategy

Injection, Triamcinolone Hexacetonide, Per 5 Mg DRUG

Ultrasound-guided injection of 20 mg of triamcinolone hexacetonide (or -acetonide) into the carpal tunnel space close to the median nerve

Also known as: Ultrasound-guided corticosteroid injection

Injection treatment strategy

Eligibility Criteria

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

You may qualify if:

• Adult (≥18 years of age)
• Patient history indicating CTS
• Neurophysiological examination performed within 6 months
• Diagnosis of CTS based on:
• Classic/probable or possible symptoms, and neurophysiological findings consistent with CTS
• Or, in case of normal neurophysiological findings:
• Classic/probable symptoms and positive physical exam findings and/or nighttime symptoms
• Mild to moderate symptoms (intermittent, interfering with everyday life, and/or disturb sleep)

You may not qualify if:

• Previous CTS surgery or corticosteroid injection in the carpal tunnel in the relevant hand
• 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.
• History suggesting underlying causes of CTS e.g. inflammatory wrist arthritis and/or flexor tenosynovitis
• Previous significant trauma or fracture, deformity or tumor in the wrist or hand in the relevant hand
• Presence of conditions affecting a normal nerve function e.g. cervical disc herniation, polyneuropathy or previous nerve injury
• 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
• Severe psychiatric or mental disorders
• Local infection or wound in the affected hand/wrist
• Any other medical condition that according to the treating physician and/or local guidelines makes adherence to treatment protocol impossible
• Inadequate birth control1, pregnancy2, and/or breastfeeding (current at screening or planned within the duration of the study)
• Known hypersensitivity to Triamcinolone Hexacetonide (Lederspan) or any of the excipients (sorbitol, polysorbate or benzyl alcohol)
• Concomitant therapy with CYP3A-inhibitors or digitalis glycosides
• Patients vaccinated or immunized with live virus vaccines within 2 weeks of treatment
• Alcohol or other substance abuse
• Language barriers

Sponsors & Collaborators

• Diakonhjemmet Hospital: lead
• Oslo University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator
• South-Eastern Norway Regional Health Authority: collaborator
• University Hospital, Akershus: collaborator

Study Sites (5)

Akershus University Hospital

Lørenskog, Akershus, 1461, Norway

Location

Department of Surgery and Anesthesiology, Diakonhjemmet Hospital

Oslo, Norge, 1450, Norway

Location

Department of Rheumatology, Diakonhjemmet Hospital

Oslo, 0319, Norway

Location

Department of Orthopedic Surgery, Martina Hansens Hospital

Sandvika, Norway

Location

Department of Rheumatology, Martina Hansens Hospital

Sandvika, Norway

Location

Related Publications (5)

• 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.

  PMID: 10918269 BACKGROUND

• 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.

  PMID: 8245050 BACKGROUND

• 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.

  PMID: 15866967 BACKGROUND

• 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.

  PMID: 10146874 BACKGROUND

• 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.

  PMID: 21479777 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Injections; triamcinolone hexacetonide

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hilde B Hammer, MD, PhD

  Diakonhjemmet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants in both strategy arms will have the site for injection/surgery covered with a adhesive bandage prior to assessment by blinded outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm, prospective, multi-center, parallel-group, open-label assessor-blinded non-inferiority treatment strategy study

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 1, 2022
• Study Start: April 8, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

NO (5)