Condition category
Nervous System Diseases
Date applied
24/04/2018
Date assigned
02/05/2018
Last edited
04/06/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Carpal tunnel syndrome (CTS) is pressure on a nerve in the wrist that causes tingling, numbness and pain in the hand and fingers. It is commonly treated with wrist splinting, mainly during night-time, but the evidence for the effectiveness and durability of this treatment is weak. The most common type of splint used in current clinical practice is a rigid splint that immobilizes the wrist. However, it has not been established whether a rigid splint is better than a soft splint that does not immobilize the wrist. The aim of this study is to assess the effectiveness of a rigid wrist splint compared with that of a soft wrist splint in patients with CTS.

Who can participate?
Patients aged 25 to 65 with CTS

What does the study involve?
Participants are randomly allocated to treatment with either a rigid or soft wrist splint to be used at night and if possible during daytime, at first for 6 weeks. The splints are fitted with a temperature monitoring device to measure the total time during which the splint has actually been worn. The participants complete a questionnaire that measures CTS symptoms, health status, quality of life and pain at the start of treatment and after 6, 12, 24 and 52 weeks. The participants undergo physical examinations and nerve conduction testing at the start of the study and at 52 weeks.

What are the possible benefits and risks of participating?
The results from the study are of great importance to patients who will be treated in the future for CTS. They will show the long-term effects of treatment of CTS with a wrist splint. The use of a wrist splint does not have any complications and participation in the study does not cause delayed treatment time compared with routine treatment.

Where is the study run from?
Department of Orthopedics, Hässleholm-Kristianstad-Ystad (Sweden)

When is the study starting and how long is it expected to run for?
January 2018 to May 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Kamelia Tadjerbashi

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kamelia Tadjerbashi

ORCID ID

Contact details

J A Hedlunds väg 5
Kristianstad
29185
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2018/16

Study information

Scientific title

Treatment of carpal tunnel syndrome with wrist splinting: a randomized controlled trial

Acronym

Study hypothesis

Wrist splinting is effective for treatment of carpal tunnel syndrome.

Ethics approval

Regional Ethical Review Board in Lund, Sweden, 30/01/2018, ref 2018/16

Study design

Multi-centre prospective assessor-blinded randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Carpal tunnel syndrome

Intervention

A total of 112 eligible patients who accept participation and provide informed consent will be randomized according to a computer-generated list to treatment with either rigid or soft wrist splint to be used at night and if possible during daytime, initially for 6 weeks.

Group A: Splint with metal bar
A standard splint with wrist in neutral position worn at night and if possible during daytime. If after 6 weeks the patient reports large improvement, no further treatment is given. If the patient reports small or no improvement, further treatment with splint is given for another 4 weeks. If the patient reports only small or no improvement after 10-week splinting the patient will be offered surgery. Patients who refuse further treatment with wrist splinting will be offered surgery. Surgery will not be performed before 12 weeks after treatment start. If symptom recurrence occurs after improvement, the patients will be offered 4 weeks of wrist splinting. If the patient reports small or no improvement the patient will be offered surgery. Patients who refuse further treatment with wrist splinting will be offered surgery.

Group B: Soft splint
The splint is worn at night and if possible during daytime. If at the end of the 6 weeks the patient reports large improvement, no further treatment is given. If the patient reports small or no improvement the patient is offered surgery. Surgery will not be performed before 12 weeks after treatment start. If the patients reports symptom recurrence the patient will receive 4 weeks of similar splint. If the patient reports small or no improvement the patient is offered surgery.

The splints will be fitted with a temperature monitoring device to ascertain the total time during which the splint has actually been worn. The trial participants will complete a questionnaire that includes the 6-item CTS symptoms scale (CTS-6), the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale, the Euro-Qol 5-dimentions (EQ-5D) health status and quality of life measure and the palmar pain scale at trial start and at 6, 12, 24 and 52 weeks after treatment start. The participants will undergo physical examination and nerve conduction testing at trial start and at 52 weeks. The trials primary outcome is the change in the CTS-6 score from trial start, to 6 and 12 weeks and the rate of carpal tunnel release surgery at 52 weeks.

Intervention type

Device

Phase

Drug names

Primary outcome measure

1. Change in CTS symptoms, measured with the 6-item CTS symptoms scale at baseline, 6 weeks and 12 weeks
2. Rate of surgery at 52 weeks, measured in percent (proportion of patients that had surgery within 52 weeks)

Secondary outcome measures

1. TS symptoms, measured with the 6-item CTS symptoms scale score at 52 weeks
2. Activity limitations, measured with the 11-item disabilities of the arm, shoulder and hand (QuickDASH) scale score at baseline, 12 weeks and 52 weeks
3. Health status and quality of life, measured with the EQ-5D index at baseline, 12 weeks and 52 weeks
4. Grip strength, measured with the Jamar dynamometer at baseline and 52 weeks
5. Patient satisfaction, measured with the visual analogue scale (VAS) at 12 weeks and 52 weeks
6. Palmar pain, measured with the 2-item palmar pain scale at 52 weeks
7. Time to surgery, measured in weeks, within 52 weeks
8. Duration of sick leave, measured in days/weeks/months during 52 weeks
9. Adverse events

Overall trial start date

02/01/2018

Overall trial end date

31/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 04/06/2018:
1. Primary, idiopathic carpal tunnel syndrome (CTS)
2. Age 25-65 years, either sex
3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram
4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS
5. Symptom duration of at least 1 month

Previous inclusion criteria:
1. Primary, idiopathic carpal tunnel syndrome (CTS)
2. Age 25-65 years, either sex
3. Symptoms of classic or probable CTS according to the criteria in Katz hand diagram
4. Nerve conduction studies showing median neuropathy at the wrist and no other abnormalities or, in the presence of normal nerve conduction study results, two orthopedic or hand surgeons independently diagnose the patient as having CTS
5. Symptom duration of at least 1 month
6. Symptom severity score at least 1.8 on the 6-item CTS symptoms scale (CTS-6)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

112

Participant exclusion criteria

1. CTS classified as severe (thenar atrophy or 2-point discrimination exceeding 8 mm in at least 1 finger)
2. Treatment of the study hand with a wrist splint in the past year
3. Previous steroid injection for CTS in the study hand
4. Inflammatory joint disease
5. Vibration-induced neuropathy
6. Polyneuropathy
7. Current pregnancy
8. Trauma to the study hand in the past year
9. Previous CTS surgery in the study hand
10. Inability to complete questionnaires due to language difficulties or cognitive disorder
11. Severe medical illness
12. Known abuse of drugs and/or alcohol

Recruitment start date

04/06/2018

Recruitment end date

31/05/2019

Locations

Countries of recruitment

Sweden

Trial participating centre

Department of Orthopedics, Hässleholm-Kristianstad-Ystad
29185
Sweden

Sponsor information

Organisation

Region Skåne

Sponsor details

VO Ortopedi
Skånevård Kryh
Hässleholm
28125
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists intend to publish the study protocol with statistical analysis plan in an appropriate journal during 2018. Planned publication of the study results in a high-impact peer reviewed journal.

IPD sharing statement
The trialists are not allowed to share individual patient data but can consider reasonable requests from researchers. The data will be stored at the trial researchers’ institution.

Intention to publish date

30/05/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/06/2018: The following changes have been made: 1. The recruitment start date has been changed from 02/05/2018 to 04/06/2018. 2. The participant inclusion criteria have been changed.