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CompletedNCT00416117Updated Dec 27, 2006

Manual Physical Therapy and Exercise for Mechanical Neck Disorders

A Phase 2/3 interventional study of Manual Physical Therapy and Exercise and Minimal Intervention in Neck Pain and Radiculitis, sponsored by Brooke Army Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-12-27.

Sponsored by Brooke Army Medical Center · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Mounting evidence does support the combined use of manual physical therapy (MPT)and exercise for patients with cervicogenic headache and mechanical neck pain. However, there is insufficient evidence to assess the effectiveness of MPT and exercise for patients with neck disorders with radicular symptoms. Our purpose for this study was to determine the effectiveness of a manual physical therapy and exercise program as compared to a minimal intervention approach in the treatment of patients with mechanical neck pain, with or without upper extremity symptoms.

Read the detailed description

Prior to randomization, potential participants underwent a standardized history and examination of the cervical spine and upper quarter. We collected demographic information that included each patient's age; gender; medication use; imaging results; and the location, nature, and duration of symptoms. Self-report measures included the NDI and VAS pain scales. Physical exam measures included cervical range of motion measurements with a gravity inclinometer, passive accessory motion testing to assess cervical spine segmental mobility and pain provocation, an upper quarter neurological screening, and special tests commonly used to identify cervical impairments.

Participants meeting all inclusion criteria were randomized into one of two treatment groups: 1) manual physical therapy and exercise (MTE) or 2) minimal intervention (MI).

Patients in the MTE group received manual physical therapy interventions specifically targeted to impairments identified during the physical examination. Physical therapists chose manual interventions consisting of thrust and non-thrust joint manipulation/mobilization, muscle energy, and soft-tissue mobilization/stretching techniques that are commonly referenced and used in clinical practice. We provided all patients in the MTE group with a standard home exercise program of cervical retraction, deep neck flexor strengthening, and cervical rotation range of motion exercises.

Patients in the MI group received a basic treatment plan consistent with general practitioner care. We provided all patients with a basic regimen of postural advice, encouragement to maintain neck motion and daily activity levels, cervical rotation range of motion exercise, and instructions to continue any prescribed medication use. Minimalist physical therapy treatments consisted of sub-therapeutic pulsed (10%) ultrasound at 0.1w/cm2 for 10 minutes applied to the cervical spine and cervical rotation range of motion exercises. We provided these treatments to maintain the patients' expectations for physical therapy treatment and subsequent improvement, and to standardize the therapist-patient interaction time

The intervention period lasted 3 weeks with both groups receiving treatment twice weekly for up to 6 sessions. We standardized treatment time for both groups by using a one-hour initial evaluation and treatment session and thirty-minute follow-up treatment sessions. Patients did not have to complete all six visits if their symptoms had fully resolved. The treating therapist instructed and supervised all exercises to ensure proper patient technique and understanding.

We collected outcome measure data at baseline and at the patient's 3-week, 6-week and 1-year follow-ups. All outcome measures were collected by physical therapists that were blinded to treatment group allocation.

02

Conditions studied

  • Neck Pain
  • Radiculitis

Keywords

  • Neck pain
  • Cervical pain
  • Radicular pain
  • Manual therapy
  • Mobilization
  • Manipulation
03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Brooke Army Medical Center is the lead sponsor of 92 studies on the registry; 11 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • primary complaint of neck pain, with or without unilateral upper extremity symptoms
  • age greater than 18
  • Neck Disability Index (NDI) score greater than or equal to 10 points
  • Composite Visual Analog Scale (VAS) score greater than or equal to 30mm
  • Eligible for military health care
  • Reside within one hour of the military treatment facilities
  • Possess sufficient English language skills to complete all questionnaires

Exclusion criteria

Exclusion Criteria:

  • whiplash injury within the past 6 weeks
  • history of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
  • pending legal action regarding their neck pain
  • diagnosis of central cervical spinal stenosis
  • bilateral upper extremity symptoms
  • two positive neurological findings at the same nerve root level
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
100 participants

Interventions

  • ProcedureManual Physical Therapy and Exercise
  • ProcedureMinimal Intervention
06

What researchers measure

Primary outcomes

  1. Neck Disability Index

  2. Visual analog scale for neck pain

  3. Visual analog scale for upper extremity pain

  4. Global rating of change

Secondary outcomes

  1. Treatment success rates based on GRC

  2. Additional healthcare utilization

07

Study locations

2 sites
  • Brooke Army Medical Center
    Fort Sam Houston, Texas 78234, United States
  • Wilford Hall Medical Center
    Lackland Air Force Base, Texas 78236, United States
08

References and documents

Publications

  • Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e. PubMed 18923311 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00416117
Lead sponsor
Brooke Army Medical Center
Collaborators
59th Medical Wing
First posted
Dec 27, 2006
Start date
Jul 2001
Completion
Jun 2004
Last update
Dec 27, 2006

Study contacts

Michael J Walker, PT, DSc
principal investigator · Brooke Army Medical Center
View the source record on ClinicalTrials.gov ↗

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