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

NCT02451267 | Completed

• 1 other identifier: COM-0016-15
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain

Keywords

neck pain; aerobic exercise; cervical pain

Outcome Measures

Primary Outcomes (1)

• Global Rating of Change (GROC) scale

  rating pain severity on a scale from -7 to 7

  following 6 weeks of treatment, 3 months and 6 months

Secondary Outcomes (8)

• Change from baseline in Neck Disability Index at 6 weeks

  following 6 weeks of treatment

• Change from baseline in Fear Avoidance Beliefs Questionnaire

  following 6 weeks of treatment

• Change from baseline in cervical range of motion

  following 6 weeks of treatment

• long term follow up assessment of VAS

  3 months and 6 months

• long term follow up assessment Neck Disability Index

  3 months and 6 months

Study Arms (4)

positive CPR: research group

EXPERIMENTAL

physical therapy treatment with aerobic exercise

Other: physical therapy treatment with aerobic exercise

negative CPR: research group

EXPERIMENTAL

physical therapy treatment with aerobic exercise

Other: physical therapy treatment with aerobic exercise

positive CPR: control group

ACTIVE COMPARATOR

physical therapy treatment

Other: physical therapy treatment

negative CPR: control group

ACTIVE COMPARATOR

physical therapy treatment

Other: physical therapy treatment

Interventions

physical therapy treatment with aerobic exercise OTHER

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

negative CPR: research group; positive CPR: research group

physical therapy treatment OTHER

neck exercise strengthening program with neck massage

negative CPR: control group; positive CPR: control group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clalit Health Services: lead
• University of Haifa: collaborator

Study Sites (1)

Clalit Health Service

Nazareth, Israel

Location

Related Publications (3)

• 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.

  PMID: 24377062 BACKGROUND

• 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.

  PMID: 19046448 BACKGROUND

• 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.

  PMID: 33730206 DERIVED

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gali Dar, PhD

  University of Haifa, Department of Physical Therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2015
• First Posted: May 21, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

IL (1)