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

Jordan Miller, Graduate Student

Status: Completed

Conditions: Whiplash Injuries

Treatments: Other: Manual therapy once/week for 6 weeks; Other: Manual therapy twice/week for 3 weeks; Other: Manual therapy once/week for 3 weeks; Behavioral: Exercise and education once/week for 6 weeks; Behavioral: Exercise and education 3 times/week for 6 weeks; Behavioral: Exercise and education twice/week for 6 weeks; Other: Manual therapy twice/week for 6 weeks; Other: Manual therapy 3 times/week for 3 weeks; Other: Manual therapy 3 times/week for 6 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT01957033

13-569

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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10 participants in 9 patient groups

Duration 6 weeks, frequency 3/week

Experimental group

Description:

Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks

Treatment:

Other: Manual therapy 3 times/week for 6 weeks

Behavioral: Exercise and education 3 times/week for 6 weeks

Duration 6 weeks, Frequency twice/week

Experimental group

Description:

Exercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks

Treatment:

Behavioral: Exercise and education twice/week for 6 weeks

Other: Manual therapy twice/week for 6 weeks

Duration 6 weeks, Frequency once/week

Experimental group

Description:

Exercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks

Treatment:

Other: Manual therapy once/week for 6 weeks

Behavioral: Exercise and education once/week for 6 weeks

Duration 3 weeks, Frequency 3 times/week

Experimental group

Description:

Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks

Treatment:

Other: Manual therapy 3 times/week for 3 weeks

Behavioral: Exercise and education 3 times/week for 6 weeks

Duration 3 weeks, Frequency twice/week

Experimental group

Description:

Exercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks

Treatment:

Other: Manual therapy twice/week for 3 weeks

Behavioral: Exercise and education twice/week for 6 weeks

Duration 3 weeks, frequency once/week

Experimental group

Description:

Exercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks

Treatment:

Other: Manual therapy once/week for 3 weeks

Behavioral: Exercise and education once/week for 6 weeks

Duration 0 weeks, Frequency 3 times/week

Experimental group

Description:

Exercise and education 3 times/week for 6 weeks No manual therapy

Treatment:

Behavioral: Exercise and education 3 times/week for 6 weeks

Duration 0 weeks, Frequency twice/week

Experimental group

Description:

Exercise and education twice/week for 6 weeks. No manual therapy

Treatment:

Behavioral: Exercise and education twice/week for 6 weeks

Duration 0 weeks, Frequency once/week

Experimental group

Description:

Exercise and education once/week for 6 weeks No manual therapy

Treatment:

Behavioral: Exercise and education once/week for 6 weeks