Neck PainNCT01750736
Manual Therapy and Augmented Exercise for Neck Pain
A study testing Augmented Exercise and Manual Therapy and General Exercise and Manual Therapy in people with Neck Pain, run by Des Moines University at 3 sites in United States.
Trial summary
Manual therapy and exercise have shown to be beneficial for people with neck pain, however it is not clear how outcomes following a general exercise program compare to specific exercises intended to augment a specific manual/hands-on intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Augmented Exercise and Manual Therapy and General Exercise and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Jun 2013
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with complaint of neck pain, neck motion limitations, pain at end-range neck ROM, limited cervical/cervical and thoracic joint mobility, neck pain with manual segmental examination
Who cannot join
- The presence of any red flags (i.e. tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, signs and symptoms of vertebrobasilar insufficiency, etc.), use of blood thinners, whiplash injury in the past 6 weeks, evidence of central nervous system involvement (such as hyperreflexia, sensory disturbances in the hands, unsteadiness during walking, etc.), history of spinal surgery, workers compensation or pending legal action regarding their neck pain, insufficient English language skills to complete questionnaires, unable to comply with schedule
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Des Moines University
Des Moines, Iowa, 50325
Walsh University
North Canton, Ohio, 44720
Youngstown State University
Youngstown, Ohio, 44555
About this study
Official title: The Use of a Home Exercise Program to Augment a Manual Therapy Intervention: a Randomized Controlled Trial
Manual therapy and exercise have shown to be beneficial for people with neck pain, however it is not clear how outcomes following a general exercise program compare to specific exercises intended to augment a specific manual/hands-on intervention. This study will compare outcomes following manual therapy and a specific exercise program with manual therapy and a general exercise program.
Read the detailed description
The purpose of this study is to determine if specific neck exercises intended to augment specific manual therapy treatments result in better outcomes than standard neck exercises in people with neck pain. Clinical tests and measurements as well as patient questionnaires will be completed and compared between groups.
A secondary purpose is to determine if self report of activity is correlated with functional improvements. We hypothesize that a specifically applied home exercise that augments the effects of the manual therapy intervention will lead to improvements in outcomes in patients with neck pain. We hypothesize that higher reports of self activity will be correlated with improvements in outcomes.
- Conditions
- Neck Pain
- Being tested
- Augmented Exercise and Manual Therapy, General Exercise and Manual Therapy
- Keywords
- Augmented Exercise, Cervicalgia, Manual Therapy, Manipulation, Quantitative Sensory
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Exercise and Manual TherapyOther
Also called Manipulation, Mobilization, Self-Mobilization
Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform the augmented exercise at home and at each data collection session.
General Exercise and Manual TherapyOther
Also called Manipulation, Mobilization, Self-Mobilization
Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform general range of motion exercises for the neck at home and at each data collection session.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Exercise and Manual Therapy | Experimental | Subjects will receive manual therapy according to clinical guidelines followed by instruction in a specific exercise to augment the specific manual treatment provided. Receives: Other: Augmented Exercise and Manual Therapy |
| General Exercise and Manual Therapy | Active comparator | Subjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise. Receives: Other: General Exercise and Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck Disability Index (NDI)
A functional questionnaire completed by the subject
Measured: baseline; 36-48 hours; 96 hours
Secondary outcomes (4)
Change in Numeric Pain Rating Scale (NPRS)
Measured: baseline; 36-48 hours; 96 hours
Change in Self Reported Activity Scale (SAA)
Measured: Baseline; 36-48 hours; 96 hours
Change in Pressure Pain Threshold (PPT)
Measured: Baseline; Immediate post intervention; 36-48 hours; 96 hours
Change in Vibratory Measure
A specialized tool is used to measure sensory threshold; it is a hand-held sensor with a small vibrating tip held against the skin.
This device measures how the nerves react to vibration. The procedure is non-invasive. Little or no discomfort should be felt during the test.
Measured: Baseline; Immediate post intervention; 36-48 hours; 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Des Moines University
- Sponsor type
- University, hospital or other
- Collaborators
- Walsh University, Youngstown State University
- Responsible party
- Principal investigator, Shannon Petersen, Des Moines University
- Investigators
- Shannon Petersen, DScPT, Principal investigator, Des Moines University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01750736
- Sponsor's protocol ID
- DMUPT-001
- Status last verified
- Feb 2015
- First submitted
- 11 Dec 2012
- Last updated
- 12 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Home Exercise Program to Augment a Manual Therapy Intervention: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01750736
- Acronym / sponsor ID
- DMUPT-001
- Conditions
- Neck Pain
- Keywords
- Augmented Exercise, Cervicalgia, Manual Therapy, Manipulation, Quantitative Sensory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Des Moines UniversityUniversity, hospital or other
- Collaborators
- Walsh University, Youngstown State University
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Dec 2012 (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.
Manual therapy and exercise have shown to be beneficial for people with neck pain, however it is not clear how outcomes following a general exercise program compare to specific exercises intended to augment a specific manual/hands-on intervention. This study will compare outcomes following manual therapy and a specific exercise program with manual therapy and a general exercise program.
Detailed description
The purpose of this study is to determine if specific neck exercises intended to augment specific manual therapy treatments result in better outcomes than standard neck exercises in people with neck pain. Clinical tests and measurements as well as patient questionnaires will be completed and compared between groups.
A secondary purpose is to determine if self report of activity is correlated with functional improvements. We hypothesize that a specifically applied home exercise that augments the effects of the manual therapy intervention will lead to improvements in outcomes in patients with neck pain. We hypothesize that higher reports of self activity will be correlated with improvements in outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Exercise and Manual Therapy | Experimental | Other: Augmented Exercise and Manual TherapySubjects will receive manual therapy according to clinical guidelines followed by instruction in a specific exercise to augment the specific manual treatment provided. |
| General Exercise and Manual Therapy | Active comparator | Other: General Exercise and Manual TherapySubjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with complaint of neck pain, neck motion limitations, pain at end-range neck ROM, limited cervical/cervical and thoracic joint mobility, neck pain with manual segmental examination
Key exclusion criteria (1 listed)
- The presence of any red flags (i.e. tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, signs and symptoms of vertebrobasilar insufficiency, etc.), use of blood thinners, whiplash injury in the past 6 weeks, evidence of central nervous system involvement (such as hyperreflexia, sensory disturbances in the hands, unsteadiness during walking, etc.), history of spinal surgery, workers compensation or pending legal action regarding their neck pain, insufficient English language skills to complete questionnaires, unable to comply with schedule
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 |
|---|---|---|
| Augmented Exercise and Manual TherapyAlso: Manipulation, Mobilization, Self-MobilizationSession 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform the augmented exercise at home and at each data collection session. | Other | Augmented Exercise and Manual Therapy |
| General Exercise and Manual TherapyAlso: Manipulation, Mobilization, Self-MobilizationSession 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform general range of motion exercises for the neck at home and at each data collection session. | Other | General Exercise and Manual Therapy |
Primary outcome
Change in Neck Disability Index (NDI)
Time frame: baseline; 36-48 hours; 96 hours
A functional questionnaire completed by the subject
4 secondary outcomes
Change in Numeric Pain Rating Scale (NPRS)
Time frame: baseline; 36-48 hours; 96 hours
Change in Self Reported Activity Scale (SAA)
Time frame: Baseline; 36-48 hours; 96 hours
Change in Pressure Pain Threshold (PPT)
Time frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours
Change in Vibratory Measure
Time frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours
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 12 Feb 2015.
Related trials for Neck Pain
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain
Not yet recruiting
Effect of Excercises on Pain , Disability and Craniovertebral Angle in Patients With Forward Head Posture.
Farward Head Posture
Not yet recruitingObservational study
Agreement Between CSI and IASP Pain Classification in Chronic Cervical Myofascial Pain
Myofascial Pain Syndrome - Neck
RecruitingObservational study
Upper Extremity Exercise Capacity in Chronic Non-specific Neck Pain
Neck Pain
RecruitingObservational study
The Association Between Smartphone Overuse and Mechanical Neck Pain Among Galala University Students
Mechanical Neck Pain, Forward Head Posture (FHP)
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.
Shannon Petersen, DScPT principal investigator
Des Moines University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Exercise and Manual Therapy and General Exercise and Manual Therapy in people with Neck Pain, run by Des Moines University at 3 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 1 inclusion and 1 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 12 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Change in Neck Disability Index (NDI) (time frame: baseline; 36-48 hours; 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2015.