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Completed

NCT Number: NCT01957033

Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.

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Key information

Conditions

Whiplash Injuries Behavior Motor Activity Neck Injuries Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lifemark Health, Hamilton, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adults ≥ 21 years
  • main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache.
  • pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).

Exclusion criteria

  • non-mechanical sources of neck pain or over-riding comorbidity listed below:
  • rheumatoid arthritis
  • neurological diseases
  • fractures
  • dislocation
  • rheumatoid arthritis
  • upper motor neuron dysfunction or malignancy
  • pregnant women
  • closed head injury
  • on steroid-based medications within the past 6 months.

Treatment and study plan

Exercise and education once/week for 6 weeks

Behavioral

Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book

Exercise and education twice/week for 6 weeks

Behavioral

Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.

Exercise and education 3 times/week for 6 weeks

Behavioral

Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.

Manual therapy once/week for 3 weeks

Other

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Manual therapy twice/week for 3 weeks

Other

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Manual therapy 3 times/week for 3 weeks

Other

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Manual therapy once/week for 6 weeks

Other

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Manual therapy twice/week for 6 weeks

Other

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Manual therapy 3 times/week for 6 weeks

Other

Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.

Primary outcomes

  1. Feasibility

    Time frame: 1 year

    As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.

  2. Pain

    Time frame: 12 weeks (end of treatment) and 6- and 12- month follow-ups

    Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.

  3. Function

    Time frame: 12 weeks (end of treatment) and 6- and 12- month follow-up

    Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.

Secondary outcomes

  1. Fidelity

    Time frame: 1 year

    As a pilot study, the secondary outcome of interest is treatment fidelity. We will measure this through ability of health care providers to provide treatment at the dosage described in the protocol.

  2. Psychological measures

    Time frame: 12 weeks (end of treatment)

    Catastrophic thinking measured by Pain Catastrophizing Scale (PCS) Anxiety and Depression measured by Hospital Anxiety and Depression Scale (HADS) Psychological distress measured by Trauma Anxiety and Distress Scale (TADS)

  3. Psychophysical measures

    Time frame: 12 weeks (end of treatment)

    Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)

  4. Motor coordination

    Time frame: 12 weeks (end of treatment)

    Neck Walk Index (NWI)

  5. Health Status

    Time frame: 12 weeks (end of study) and 6- and 12- month follow-ups

    Measured by SF-36

  6. Global perceived effect

    Time frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups

    Global perceived effect will be measured on a 7 point scale (-3 to +3)

  7. Upper extremity function

    Time frame: 12 weeks (end of treatment) and 6- and 12-month follow-ups

    As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).

Sponsors and collaborators

Lead sponsor

Jordan Miller, Graduate Student

Other

Collaborators

  • Physiotherapy Foundation of Canada

Registry information

Official study title

Clinical and Biological Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 8, 2013
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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