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.
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
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.
- Conditions
- Neck Pain, Radiculitis
- 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.
Neck Disability Index
Visual analog scale for neck pain
Visual analog scale for upper extremity pain
Global rating of change
Secondary outcomes (2)
Treatment success rates based on GRC
Additional healthcare utilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2006 (estimated)
- Study startJul 2001
- Study completionJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Collaborators
- 59th Medical Wing
- Investigators
- Michael J Walker, PT, DSc, Principal investigator, Brooke Army Medical Center
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manual Physical Therapy and Exercise for Mechanical Neck Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00416117
- Acronym / sponsor ID
- C.2001.123
- Conditions
- Neck Pain, Radiculitis
- Keywords
- Neck pain, Cervical pain, Radicular pain, Manual therapy, Mobilization, Manipulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Collaborators
- 59th Medical Wing
- Study start
- Jul 2001
- Study completion
- Jun 2004
- First posted
- 27 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Physical Therapy and Exercise | Procedure or surgery | – |
| Minimal Intervention | Procedure or surgery | – |
Primary outcome
Neck Disability Index
Visual analog scale for neck pain
Visual analog scale for upper extremity pain
Global rating of change
2 secondary outcomes
Treatment success rates based on GRC
Additional healthcare utilization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2006.
- Derived from this study: PubMed 18923311Walker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Walker, PT, DSc principal investigator
Brooke Army Medical Center
2 sites in 1 country: see every site and its status.
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.