NCT07324811

Brief Summary

Whiplash-associated disorders are a common cause of persistent neck pain following traffic accidents and are frequently associated with impairments in cervical motor control, pain, and functional disability. Therapeutic exercise aimed at restoring cervical motor control has shown promising results; however, evidence regarding the effectiveness of structured home-based exercise programs compared with conventional physiotherapy remains limited. The aim of this study was to compare the effectiveness of a home-based cervical motor control exercise program versus conventional physiotherapy in patients with whiplash-associated neck pain. A randomized controlled trial with two parallel groups was conducted. Patients diagnosed with whiplash-associated neck pain were randomly assigned to either an experimental group performing a structured home-based cervical motor control exercise program or a control group receiving conventional physiotherapy based on manual therapy and cervical mobilization techniques. Outcome measures included pain intensity assessed using the Visual Analogue Scale, functional disability measured with the Neck Disability Index, and active cervical range of motion. Assessments were performed at baseline and after an eight-week intervention period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 23, 2025

Last Update Submit

December 23, 2025

Conditions

Keywords

Whiplashpainexercise

Outcome Measures

Primary Outcomes (1)

  • pain

    measured using the visual analogue pain scale (VAS) (where 0 is the least possible pain and 10 is the maximum possible pain)

    2 months

Secondary Outcomes (1)

  • range of motion

    2 months

Study Arms (2)

home-based cervical motor control exercise programme

EXPERIMENTAL

home-based cervical motor control exercise programme monitored by physiotherapists

Procedure: home-based cervical motor control exercise programme

conventional physiotherapy treatment

ACTIVE COMPARATOR

Conventional physiotherapy treatment including passive therapies (manual therapy) in the physiotherapy clinic.

Procedure: conventional physiotherapy treatment

Interventions

home-based programme of active cervical motor control exercises supervised by physiotherapists

home-based cervical motor control exercise programme

Conventional physiotherapy treatment with passive therapy (manual therapy) carried out in a physiotherapy clinic.

conventional physiotherapy treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who met the following criteria were included:
  • Age between 18 and 65 years.
  • Clinical diagnosis of post-whiplash neck pain resulting from a traffic accident.
  • Symptoms lasting longer than four weeks.
  • Presence of neck pain with a minimum intensity of 3 points on the Visual Analogue Scale.
  • Ability to understand and follow the instructions of the home exercise programme.
  • Signed informed consent.

You may not qualify if:

  • Patients with the following conditions were excluded:
  • Signs of severe neurological compromise or significant structural cervical pathology (fractures, cervical instability, myelopathy).
  • History of cervical surgery.
  • Rheumatic, neurological, or systemic diseases that could influence the results.
  • Previous physiotherapy treatment for the same episode in the three months prior to the study.
  • Pregnancy or any medical contraindication for therapeutic exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Pontificia de Salamanca

Salamanca, 37002, Spain

Location

Related Publications (4)

  • Randlov A, Ostergaard M, Manniche C, Kryger P, Jordan A, Heegaard S, Holm B. Intensive dynamic training for females with chronic neck/shoulder pain. A randomized controlled trial. Clin Rehabil. 1998 Jun;12(3):200-10. doi: 10.1191/026921598666881319.

  • Jordan A, Bendix T, Nielsen H, Hansen FR, Host D, Winkel A. Intensive training, physiotherapy, or manipulation for patients with chronic neck pain. A prospective, single-blinded, randomized clinical trial. Spine (Phila Pa 1976). 1998 Feb 1;23(3):311-8; discussion 319. doi: 10.1097/00007632-199802010-00005.

  • Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H. A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):788-97; discussion 798-9. doi: 10.1097/00007632-200104010-00020.

  • Kjellman GV, Skargren EI, Oberg BE. A critical analysis of randomised clinical trials on neck pain and treatment efficacy. A review of the literature. Scand J Rehabil Med. 1999 Sep;31(3):139-52. doi: 10.1080/003655099444489.

MeSH Terms

Conditions

Uterine Cervical DiseasesWhiplash InjuriesPainMotor Activity

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesNeck InjuriesWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinding
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 23, 2025

First Posted

January 8, 2026

Study Start

January 10, 2025

Primary Completion

April 10, 2025

Study Completion

September 10, 2025

Last Updated

January 8, 2026

Record last verified: 2025-12

Locations