The NEXERCISE-trial: Reshaping Exercise Programs for Patients With Non-specific Neck Pain

NCT04749823 | Completed

• 1 other identifier: BC-5419
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The Nexercise-trial is a blended treatment program for patients with chronic non-specific neck pain. We will investigate whether a blended treatment approach, combining specific neck exercises and general aerobic exercises, has better outcome (on medical impact for the patient and socio-economic impact) than a specific neck exercise program alone or a general aerobic exercise program alone.

Conditions

Neck Pain; Chronic Pain

Keywords

local neck exercises; general aerobic exercises; pain intensity; cost effectiveness

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Pain intensity by the Brief Pain Inventory (BPI). The BPI includes four ratings of pain intensity (items 3-7), and seven other ratings on the impact of pain. Intensity is recorded on numerical scales from zero (no pain) to ten (pain as bad as you can imagine). Also, intensity is rated at the time of completing the questionnaires (pain now) as well as its worst, least, and average over the past day or week. The BPI also records the location of the pain on a diagram of a human figure. Patients are also asked to select words that best describe their pain and to indicate the extent and duration of pain relief obtained from analgesics.

  After treatment (12weeks)

Secondary Outcomes (14)

• Pain sensitivity

  Baseline and after 12 weeks treatment

• Central sensitivity

  Baseline and after 12 weeks treatment

• Pain intensity

  baseline, after 6 weeks of treatment and 3 months after treatment

• Neck pain-related disability

  Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

• Health-related quality of life

  Baseline, after 6 weeks treatment, after 12 weeks treatment, after 3 months

Study Arms (3)

Blended treatment program

EXPERIMENTAL

The blended treatment program will consist of a combination of specific active exercises of the neck and general aerobic exercises. This contains a program of 12 weeks, including 9 supervised online sessions supplemented with 1 to 3 individual home exercises sessions without supervision per week, with a total of 3 sessions/week.

Other: Blended treatment program

Specific strength exercise program

ACTIVE COMPARATOR

This group will receive an exercise program with specific strength exercises of the neck muscles. Within a 12-week period, patients will receive 9 online treatment sessions under supervision and 1 to 3 additional home exercise sessions without supervision, with a total of 3 sessions/week..

Other: Specific strength exercise program

General aerobic exercise program

ACTIVE COMPARATOR

This control group will perform general aerobic exercises. Within a 12-week period, patients will be instructed to perform a general aerobic exercise session 3 times a week.

Other: General aerobic exercise program

Interventions

Blended treatment program OTHER

A combined treatment program with specific active neck exercises and general aerobic training in counteractive amount will be executed during 12 weeks. Nine supervised sessions will be supplemented with 1 to 3 weekly unsupervised home exercise sessions.

Blended treatment program

Specific strength exercise program OTHER

This program includes an individual, patient-tailored exercise program with the aim of retraining the neck musculature. A detailed exercise programme will be constructed in which all exercises are listed with the amount of repetitions and series of each exercise. Strength exercises will be performed by means of dumbbells with different weights and elastic bands with different degrees of resistance. The amount of weight or resistance, and the amount of series and repetitions will be evaluated during the first session. This exercise programme will be re-evaluated repeatedly during the course of the program. Specific strength neck exercises will be performed for 30 minutes. Nine supervised sessions will be supplemented with 1 to 3 weekly unsupervised home exercise sessions.

Specific strength exercise program

General aerobic exercise program OTHER

This control group will receive a general aerobic exercise program. Within a 12-week period, patients will be instructed to perform a general aerobic exercise session 3 times a week.

General aerobic exercise program

Eligibility Criteria

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

You may qualify if:

• Neck pain \> 3 months
• Mean pain intensity \> 3/10 during the preceding month
• Native Dutch speaker
• Being able to walk normally

You may not qualify if:

• People with specific causes of neck pain (such as cervical disc herniation with nerve root impingement, severe osteoarthritis, fractures)
• Major depression or psychiatric illness
• Life threatening, metabolic, cardiovascular, neurologic, systemic diseases, diagnosed sleeping disorder
• Pregnancy or given birth in the preceding year
• History of head, neck or shoulder surgery
• Fibromyalgia and chronic fatigue syndrome
• Body mass index \> 30 kg/m2

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Department of rehabilitation sciences (Ghent University)

Ghent, Gente, 9000, Belgium

Location

MeSH Terms

Conditions

Neck Pain; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mira Meeus, Prof.Dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: February 11, 2021
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

BE (1)