Neck PainNCT01760590
The Effects of Thoracic Spine Manipulation in Individuals With Non-traumatic Cervical Pain
A study testing Manual Manipulation and Mobilization in people with Neck Pain and Cervical Pain, run by Keystone Rehabilitation Systems at 2 sites in United States.
Trial summary
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in individuals with nontraumatic cervical pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain, Cervical Pain
- What is being tested?
- Manual Manipulation and Mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Dec 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with non-traumatic Neck Pain
- Between ages 18 - 60
Who cannot join
- Red flags such as:
- leg weakness
- night pain
- history of cancer
- upper motor neuron signs
- infection
Show all 15Show fewer
- tumors
- osteoporosis
- fracture
- history of whiplash within 6 weeks
- cervical stenosis
- CNS involvement
- signs consistent with nerve root compression
- previous surgery
- pending legal action
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Keystone Rehabilitation Systems
Bridgeville, Pennsylvania, 15017
Joseph Brence, DPT, 412-257-9660
Joseph B Brence, DPT
- Recruiting
Allegheny Chesapeake Physical Therapy
Pittsburgh, Pennsylvania, 15218
Dave Thompson, DPT, 412-244-7750
Dave Thompson, DPT
About this study
Official title: The Effects of Thoracic Spine Manipulation and Mobilization in Individuals With Nontraumatic Cervical Pain
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in individuals with nontraumatic cervical pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007)
Read the detailed description
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in individuals with nontraumatic cervical pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007)
The subjects will be patients at clinics owned by Physiotherapy Associates, Fit Physical Therapy, and Allegheny and Chesapeake PT who seek physical therapy services for nontraumatic neck pain. Participation will be entirely voluntary.
Patients will be offered a chance to participate in the research project on their initial visit for Physical Therapy.
If the PT identifies an appropriate patient they will ask if they are interested in being a research subject. The Physical Therapist recruiting subjects all have completed their Doctor of Physical Therapy Degree and have advanced training in manual Physical Therapy. The techniques employed are considered standard practice and are defined as entry level skills by the Commission of Accredidation of Physical Therapy Programs. These techniques are typically taught in DPT degree programs.
If the patient is interested, a description of the study will be provided. A consent form will be given to all participants.
Research Procedures:
- Patients who present to one of three Physical Therapy clinics, under the direction of three advanced clinicians, will be assessed for their potential participation in this research. The treating clinician will recruit appropriate subjects based on includion and exclusion criteria and their PT diagnosis. Those that meet the inclusion and exclusion criteria will be given the consent form to determine if they wish to participate. Each researcher will have formal training in these techniques. Two of the clinicians have received their Orthopedic Clinical Specialists certification under the examination prcess outlined by the American Physical Therapy association. A third researcher has obtained his fellowship designation from the American Academy of Orthopedic Manual Physical Therapy. This skill is deemed entry level by the the Accredidation Board of the American Physical Therapy Educators. All Therapists will undergo a prestudy hands on education program to ensure the use of similar techniques.
- If after reading the consent form they agree to participate, they will be given one additional form, the Pain Catastrophizing scale, and asked to complete it. The scale, NDI, cervical ROM, age, and birthdate will be recorded on a sheet contained in the patient's clinical chart.
- The PT evaluation will then be completed.
- They will then be randomized into one of two groups based on a roll of a die: Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded. Group Two: Grade 5 mobilization group: this group wil receive a grade 5 mobilization.
- Additional treatment including patient eduation, modalities, and exercise will be completed as the PT deems appropriate,
- The second visit will be scheduled within 24 to 48 hours.
- The patient will complete the same forms as were completed during the initial evaluation (NDI, PCS) and return them so that the results may berecorded on the record sheet identified only with date of birth.
- The treatment will be repeated including the manual technique and other treatment deemed appropriate by the PT. Additional treatment between the second and last visits will be under the sole discretion on the treating PT.
- On the discharge visit, the patient will receive the same forms, and be asked how much, in terms of %, they feel they have improved. This information will be recorded on the deidentified sheet.
Home exercise programs and patient educaiton will be issued as appropriate.
A bubble goniometer will be used for range of motion assessment. This is a standard plastic device used in PT practice. A Wagner FDX digital force gauge algometer will measure pain pressure thresholds.
Where survey instruments are involved, a copy of the instrument and, for surveys not created for this project, assurance that the principal investigator has proper approval to use them.
The Neck Disability Index or NDI will be used. It is the professional standard for outcomes measures for people with neck pain.
It has been shown to be valid and reliable.
The Pain Castrophizing Scale will be used. It is a valid and reliable measure of a patient's perception of pain and is commonly used.
The data will be collected by the treating Physical Therapist who has access to the patient record for treatment purposes.
The data will not be used for purposes other that patient care and research purposes.
Patient's data measures will be collected on a de-identified sheet marked with the patients birthday. The will be kept in a locked area in the clinic. The lead investigator will have access to the data when the study is completed and transfer it to a locked file cabinet in his office for data assessment.
Following treatment the patient may have mild soreness over the area which was treated. This typically diminishes in 24 hours. the patient will be informed of this potential soreness. The use of heat and /or ice, exercise, and patient education provided by the Therapist concerning activities and posture will also lessen the soreness.
- Conditions
- Neck Pain, Cervical Pain
- Being tested
- Manual Manipulation, Mobilization
- Keywords
- neck pain, cervical pain, pain pressure thresholds, pain catastrophizing
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual ManipulationProcedure or surgery
Also called Thrust
A grade 5 thrust to the thoracic spine
MobilizationProcedure or surgery
Also called Springing
A grade 1-4 mobilization directed at thoracic spine
| Study group | Role | What they receive |
|---|---|---|
| Manual Manipulation | Experimental | Patients will be randomized to receive a thrust manipulation Receives: Procedure: Manual Manipulation |
| Manual Mobilization | Experimental | Patients will be randomized to receive mobilization Receives: Procedure: Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Verbal Descriptor on a scale from 0-10
Measured: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Neck Disability
Neck Disability Index
Measured: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Pain Pressure Thresholds
Using Wagner FDX Algometer
Measured: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Secondary outcomes (4)
Pain Catastrophizing
Pain Catastrophizing Scale
Measured: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Global Rating of Change
% of perceived change following intervention
Measured: Baseline will be assessed at Week 1 and change from this measurement taken at Week 4
ROM
Bubble goniometry of cervical motion
Measured: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Clinical Equipoise
This will measure examiners C.E
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keystone Rehabilitation Systems
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Brence, Keystone Rehabilitation Systems
- Investigators
- Steve Karas, DSc, Study director, Chatham UniversityJoseph B Brence, DPT, Principal investigator, Keystone Rehabilitation Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01760590
- Sponsor's protocol ID
- KRS2
- Status last verified
- Jan 2013
- First submitted
- 22 Dec 2012
- Last updated
- 4 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Thoracic Spine Manipulation and Mobilization in Individuals With Nontraumatic Cervical Pain
- ClinicalTrials.gov ID
- NCT01760590
- Acronym / sponsor ID
- KRS2
- Conditions
- Neck Pain, Cervical Pain
- Keywords
- neck pain, cervical pain, pain pressure thresholds, pain catastrophizing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Keystone Rehabilitation SystemsUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 4 Jan 2013 (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.
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in individuals with nontraumatic cervical pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007)
Detailed description
The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in individuals with nontraumatic cervical pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007)
The subjects will be patients at clinics owned by Physiotherapy Associates, Fit Physical Therapy, and Allegheny and Chesapeake PT who seek physical therapy services for nontraumatic neck pain. Participation will be entirely voluntary.
Patients will be offered a chance to participate in the research project on their initial visit for Physical Therapy.
If the PT identifies an appropriate patient they will ask if they are interested in being a research subject. The Physical Therapist recruiting subjects all have completed their Doctor of Physical Therapy Degree and have advanced training in manual Physical Therapy. The techniques employed are considered standard practice and are defined as entry level skills by the Commission of Accredidation of Physical Therapy Programs. These techniques are typically taught in DPT degree programs.
If the patient is interested, a description of the study will be provided. A consent form will be given to all participants.
Research Procedures:
- Patients who present to one of three Physical Therapy clinics, under the direction of three advanced clinicians, will be assessed for their potential participation in this research. The treating clinician will recruit appropriate subjects based on includion and exclusion criteria and their PT diagnosis. Those that meet the inclusion and exclusion criteria will be given the consent form to determine if they wish to participate. Each researcher will have formal training in these techniques. Two of the clinicians have received their Orthopedic Clinical Specialists certification under the examination prcess outlined by the American Physical Therapy association. A third researcher has obtained his fellowship designation from the American Academy of Orthopedic Manual Physical Therapy. This skill is deemed entry level by the the Accredidation Board of the American Physical Therapy Educators. All Therapists will undergo a prestudy hands on education program to ensure the use of similar techniques.
- If after reading the consent form they agree to participate, they will be given one additional form, the Pain Catastrophizing scale, and asked to complete it. The scale, NDI, cervical ROM, age, and birthdate will be recorded on a sheet contained in the patient's clinical chart.
- The PT evaluation will then be completed.
- They will then be randomized into one of two groups based on a roll of a die: Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded. Group Two: Grade 5 mobilization group: this group wil receive a grade 5 mobilization.
- Additional treatment including patient eduation, modalities, and exercise will be completed as the PT deems appropriate,
- The second visit will be scheduled within 24 to 48 hours.
- The patient will complete the same forms as were completed during the initial evaluation (NDI, PCS) and return them so that the results may berecorded on the record sheet identified only with date of birth.
- The treatment will be repeated including the manual technique and other treatment deemed appropriate by the PT. Additional treatment between the second and last visits will be under the sole discretion on the treating PT.
- On the discharge visit, the patient will receive the same forms, and be asked how much, in terms of %, they feel they have improved. This information will be recorded on the deidentified sheet.
Home exercise programs and patient educaiton will be issued as appropriate.
A bubble goniometer will be used for range of motion assessment. This is a standard plastic device used in PT practice. A Wagner FDX digital force gauge algometer will measure pain pressure thresholds.
Where survey instruments are involved, a copy of the instrument and, for surveys not created for this project, assurance that the principal investigator has proper approval to use them.
The Neck Disability Index or NDI will be used. It is the professional standard for outcomes measures for people with neck pain.
It has been shown to be valid and reliable.
The Pain Castrophizing Scale will be used. It is a valid and reliable measure of a patient's perception of pain and is commonly used.
The data will be collected by the treating Physical Therapist who has access to the patient record for treatment purposes.
The data will not be used for purposes other that patient care and research purposes.
Patient's data measures will be collected on a de-identified sheet marked with the patients birthday. The will be kept in a locked area in the clinic. The lead investigator will have access to the data when the study is completed and transfer it to a locked file cabinet in his office for data assessment.
Following treatment the patient may have mild soreness over the area which was treated. This typically diminishes in 24 hours. the patient will be informed of this potential soreness. The use of heat and /or ice, exercise, and patient education provided by the Therapist concerning activities and posture will also lessen the soreness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Manipulation | Experimental | Procedure: Manual ManipulationPatients will be randomized to receive a thrust manipulation |
| Manual Mobilization | Experimental | Procedure: MobilizationPatients will be randomized to receive mobilization |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with non-traumatic Neck Pain
- Between ages 18 - 60
Key exclusion criteria (15 listed)
- leg weakness
- night pain
- history of cancer
- upper motor neuron signs
- infection
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 ManipulationAlso: ThrustA grade 5 thrust to the thoracic spine | Procedure or surgery | Manual Manipulation |
| MobilizationAlso: SpringingA grade 1-4 mobilization directed at thoracic spine | Procedure or surgery | Manual Mobilization |
Primary outcome
Pain
Time frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Verbal Descriptor on a scale from 0-10
Neck Disability
Time frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Neck Disability Index
Pain Pressure Thresholds
Time frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Using Wagner FDX Algometer
4 secondary outcomes
Pain Catastrophizing
Time frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Global Rating of Change
Time frame: Baseline will be assessed at Week 1 and change from this measurement taken at Week 4
ROM
Time frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)
Clinical Equipoise
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2013.
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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.
Steve Karas, DSc study director
Chatham University
Joseph B Brence, DPT principal investigator
Keystone Rehabilitation Systems
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Manipulation and Mobilization in people with Neck Pain and Cervical Pain, run by Keystone Rehabilitation Systems 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 4 Jan 2013. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steve Karas, DSc (412-365-2798, skaras@chatham.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)). The study lists 3 primary outcomes in all. 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 4 Jan 2013.