Neck PainNCT01318720
Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine
A study testing Manual Therapy in people with Neck Pain, run by Masefield and Cavallaro Physical Therapy at 2 sites in United States.
Trial summary
Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2009to Jun 2012
- 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
- Neck pain of less than 3 months
- No symptoms below the shoulder
- Baseline Neck Disability Index score of 10 or greater
Who cannot join
- Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc)
- History of whiplash injury within the past two months
- Diagnosis of cervical spinal stenosis
- Uni-lateral or bi-lateral upper extremity radicular symptoms
- Evidence of central nervous system involvement
- Two or more positive neurological signs consistent with nerve root involvement: myotomal muscle weakness, dermatomal sensory loss, diminished or absent reflexes
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- Prior surgery to the neck or thoracic spine
- Pending legal action regarding their neck pain, or patients with no fault or workers compensation claims
- Insufficient English language skills to complete the questionnaires
- Inability to comply with treatment and follow-up schedule
- Women who may be pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Long Island University
Brooklyn, New York, 11201
Masefield Cavallaro Physical Therapy
Brooklyn, New York, 11228
About this study
Official title: Short-Term Combined Effects of Thoracic Spine Thrust Manipulation and Cervical Spine Non-Thrust Manipulation in Patients With Mechanical Neck Pain: A RCT
Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.
- Conditions
- Neck Pain
- Being tested
- Manual Therapy
- Keywords
- Neck Pain, Thrust Manipulation, Non-Thrust Manipulation
- 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 TherapyOther
Thrust manipulation is a type of manual therapy that clinicians apply using a high-velocity, low-amplitude thrust directed at a joint(s)
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Experimental | The experimental group is receiving thoracic spine thrust manipulation and cervical spine non-thrust manipulation. Receives: Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck Disability Index (NDI)
Neck Disability Index (NDI) is a disease-specific outcome measure specifically used in patients with neck pain. The NDI has been shown to be reliable and valid in individuals with mechanical neck pain.
Measured: Short-term outcome 1 week
Secondary outcomes (1)
Global Rating of Change (GROC)
The Global Rating of Change is a outcome measure used to assess patient perceived recovery following interventions.
Measured: Short-term outcome 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2011 (estimated)
- Study startNov 2009
- Primary completionJun 2012
- Study completionJun 2012
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
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masefield and Cavallaro Physical Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Masaracchio PT, DPT, PhD(c), OCS, SCS, Masefield and Cavallaro Physical Therapy
- Investigators
- Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS, Principal investigator, Masefield Cavallaro Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318720
- Sponsor's protocol ID
- MCPT1
- Status last verified
- Apr 2015
- First submitted
- 17 Mar 2011
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Combined Effects of Thoracic Spine Thrust Manipulation and Cervical Spine Non-Thrust Manipulation in Patients With Mechanical Neck Pain: A RCT
- ClinicalTrials.gov ID
- NCT01318720
- Acronym / sponsor ID
- MCPT1
- Conditions
- Neck Pain
- Keywords
- Neck Pain, Thrust Manipulation, Non-Thrust Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Masefield and Cavallaro Physical TherapyUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 Mar 2011 (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.
Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Experimental | Other: Manual TherapyThe experimental group is receiving thoracic spine thrust manipulation and cervical spine non-thrust manipulation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Neck pain of less than 3 months
- No symptoms below the shoulder
- Baseline Neck Disability Index score of 10 or greater
Key exclusion criteria (11 listed)
- Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc)
- History of whiplash injury within the past two months
- Diagnosis of cervical spinal stenosis
- Uni-lateral or bi-lateral upper extremity radicular symptoms
- Evidence of central nervous system involvement
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 TherapyThrust manipulation is a type of manual therapy that clinicians apply using a high-velocity, low-amplitude thrust directed at a joint(s) | Other | Manipulation |
Primary outcome
Neck Disability Index (NDI)
Time frame: Short-term outcome 1 week
Neck Disability Index (NDI) is a disease-specific outcome measure specifically used in patients with neck pain. The NDI has been shown to be reliable and valid in individuals with mechanical neck pain.
1 secondary outcome
Global Rating of Change (GROC)
Time frame: Short-term outcome 1 week
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 7 Apr 2015.
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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 Masaracchio, PT, DPT, PhD(c), OCS, SCS principal investigator
Masefield Cavallaro Therapy
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 Therapy in people with Neck Pain, run by Masefield and Cavallaro Physical Therapy 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 3 inclusion and 11 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 7 Apr 2015. 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?
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 (NDI) (time frame: Short-term outcome 1 week). 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 7 Apr 2015.