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Neck PainPhase 2/3NCT00416117

Manual Physical Therapy and Exercise for Mechanical Neck Disorders

A Phase 2/3 study testing Manual Physical Therapy and Exercise and Minimal Intervention in people with Neck Pain and Radiculitis, run by Brooke Army Medical Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neck Pain, Radiculitis
What is being tested?
Manual Physical Therapy and Exercise and Minimal Intervention
Type of treatment
Surgery or procedure
How many people
100 participants
Where
2 sitesUnited States
Study dates
Jul 2001to Jun 2004
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

Other trials in United States

About this study

Official title: The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial

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.

Being tested
Manual Physical Therapy and Exercise, Minimal Intervention
Keywords
Neck pain, Cervical pain, Radicular pain, Manual therapy, Mobilization, Manipulation
Medical subject headings
Neck Pain, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Manual Physical Therapy and ExerciseProcedure or surgery

  • Minimal InterventionProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (2)
  1. Treatment success rates based on GRC

  2. Additional healthcare utilization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2006 (estimated)
  2. Study startJul 2001
  3. Study completionJun 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00416117
Sponsor's protocol ID
C.2001.123
Status last verified
Dec 2006
First submitted
26 Dec 2006
Last updated
27 Dec 2006
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Manual Physical Therapy and Exercise and Minimal Intervention in people with Neck Pain and Radiculitis, run by Brooke Army Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neck Disability Index. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00416117, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2006.

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