Clinical Prediction Rules for Identifying Patients With Chronic Neck Pain Who Will Benefit From General Aerobic Exercise

NCT ID: NCT02451267

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-03-31

Brief Summary

The aim of the study is to investigate the effect of aerobic exercise on chronic neck pain. The study will be double blind randomized controlled trial . 120 patients with neck pain will be recruited for the study and divided into a research group and control group. The research group will receive neck exercise program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders) and the control group will receive only neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. In addition, clinical prediction rule (CPR) for identifying patients with neck pain who will respond better to an aerobic treatment program will be defined.

Detailed Description

Background:Recently, Hanney et al (2013) derived a preliminary clinical prediction rule (CPR) for identifying patients with neck pain (NP) who may respond to an exercise-based treatment program. These CPRs of neck exercise has not considered aerobic exercise (AE) on NP treatment.

Aims of this study: 1) To investigate the effect of aerobic exercise on chronic neck pain;2) To derive a clinical prediction rule for identifying patients with neck pain who may benefit from aerobic treatment program; 3) To determine the prevalence of neck pain in Israel.

Study Design: Double Blind Randomized controlled trial setting: Outpatients physical therapy clinics of "Clalit Health Services" in Haifa and Western Galilee area.

Participants: Patients referred to physical therapy with a primary diagnosis of chronic non-specific NP.

Methods: Following a baseline examination in which the subjects' status on the CPR will be determined, the subjects (CPR positive and negative) will be randomized, divided into a research group and control group. The CPR status will be determined according to Hanney's paper (e.g.: neck disability Index score < 18/50 ,shoulder protraction, cervical side bending < 32°,Fear avoidance belief questionnaire-physical activity score < 15, not active on a regular basis on bicycle training). Positive CPR is accordance of having 4/5 these points.

The baseline examination will include: active and passive cervical range of motion, neurological exam (reflex, sensation, muscle testing), cervical segmental mobility (accessory movement), neck muscle length, cervical manual muscle test and posture assessment.

The research group will receive neck exercise program with neck massage and AE (leg bicycling with relaxed shoulders) and the control group will receive neck exercise program with neck massage. Both intervention will be delivered by physiotherapist over 10 treatments and will include a home exercise program. Immediate examination will be used at the last treatment (10 treatments), and at 3 and 6 month follow up examination for long-term effects.

In addition, Data collecting from physiotherapy department in "Clalit Health Services" about statistic of patients with NP who referred to physical therapy including: Prevalence, demographic and profile data

Conditions

Neck Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

positive CPR: research group

physical therapy treatment with aerobic exercise

Group Type: EXPERIMENTAL

physical therapy treatment with aerobic exercise

Intervention Type: OTHER

neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)

negative CPR: research group

physical therapy treatment with aerobic exercise

Group Type: EXPERIMENTAL

physical therapy treatment with aerobic exercise

Intervention Type: OTHER

neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)

positive CPR: control group

physical therapy treatment

Group Type: ACTIVE_COMPARATOR

physical therapy treatment

Intervention Type: OTHER

neck exercise strengthening program with neck massage

negative CPR: control group

physical therapy treatment

Group Type: ACTIVE_COMPARATOR

physical therapy treatment

Intervention Type: OTHER

neck exercise strengthening program with neck massage

Interventions

physical therapy treatment with aerobic exercise

neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)

Intervention Type: OTHER

physical therapy treatment

neck exercise strengthening program with neck massage

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• chronic neck pain (> 30 days)
• neck disability index >10
• not physical active on a daily basis

Exclusion Criteria

• past history of whiplash injury or cervical surgery
• pain radiates to the upper limb with neurological deficit (reduced reflex, sensation, muscle strength)
• complain of vertigo
• cervical spine diseases: Spondylosis, Spondylolisthesis

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Haifa

OTHER

Sponsor Role: collaborator

Clalit Health Services

OTHER

Sponsor Role: lead

Responsible Party

Prof. Refael Carel

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gali Dar, PhD

Role: STUDY_DIRECTOR

University of Haifa, Department of Physical Therapy

Locations

Clalit Health Service

Nazareth, , Israel

Countries

Israel

References

Hanney WJ, Kolber MJ, George SZ, Young I, Patel CK, Cleland JA. Development of a preliminary clinical prediction rule to identify patients with neck pain that may benefit from a standardized program of stretching and muscle performance exercise: a prospective cohort study. Int J Sports Phys Ther. 2013 Dec;8(6):756-76.

Reference Type: BACKGROUND

PMID: 24377062 (View on PubMed)

Holth HS, Werpen HK, Zwart JA, Hagen K. Physical inactivity is associated with chronic musculoskeletal complaints 11 years later: results from the Nord-Trondelag Health Study. BMC Musculoskelet Disord. 2008 Dec 1;9:159. doi: 10.1186/1471-2474-9-159.

Reference Type: BACKGROUND

PMID: 19046448 (View on PubMed)

Daher A, Dar G, Carel R. Effectiveness of combined aerobic exercise and neck-specific exercise compared to neck-specific exercise alone on work ability in neck pain patients: a secondary analysis of data from a randomized controlled trial. Int Arch Occup Environ Health. 2021 Oct;94(7):1739-1750. doi: 10.1007/s00420-021-01684-0. Epub 2021 Mar 17.

Reference Type: DERIVED

PMID: 33730206 (View on PubMed)

Other Identifiers

COM-0016-15

Identifier Type: -

Identifier Source: org_study_id