Neck PainNCT02245425
Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain
A study testing Supine Thoracic Spine Manipulation and Prone Thoracic Spine Manipulation in people with Neck Pain, run by A.T. Still University of Health Sciences at 1 site in United States.
Trial summary
This study is designed to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in people with neck pain. Read more about this study
- Who is it for?
- Ages 22 to 50 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- Supine Thoracic Spine Manipulation and Prone Thoracic Spine Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to 8 Jul 2015
- 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 22 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 22 and 50 years of age
- Primary complaint of neck pain with or without symptoms that spread down into one arm
- Overall rating of neck pain intensity is at least 3/10; the overall rating is the overall average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst pain possible".
- Neck Disability Index (NDI) score > 10 points (measure of self-reported disability with a 0 to 50 point scale where higher scores indicate higher levels of disability).
- Proficient in speaking and reading English to complete outcome questionnaires
Who cannot join
- Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
- Neck pain that spreads down into both arms
- Low back pain or thoracic origin of pain
- Nerve root involvement; defined as the presence of two or more neurological findings (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
- Diagnosis of cervical spine stenosis (narrowing of the central canal that contains the spinal cord)
- History of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery
Show all 17Show fewer
- Pending legal action related to current episode of neck pain
- Contraindications to thoracic spine thrust manipulation
- serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use)
- hyperreflexia
- unsteadiness during gait
- Nystagmus
- Loss of visual acuity
- Impaired sensation of the face
- Altered taste
- The presence of pathological reflexes
- pregnancy or considering pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Controlled Trial
This study is designed to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in people with neck pain.
The null hypothesis is that there will be no differences between the two manipulation techniques for short-term effects on neck range-of-motion, pain, and self-reported disability in people with neck pain.
Read the detailed description
Patients will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment.
Patients who meet the inclusion/exclusion criteria will be randomized to either a supine or prone thoracic spine thrust manipulation intervention.
- Conditions
- Neck Pain
- Being tested
- Supine Thoracic Spine Manipulation, Prone Thoracic Spine Manipulation
- Keywords
- Neck pain, Thoracic spine manipulation, Range of Motion, Disability
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine Thoracic Spine ManipulationOther
Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
Prone Thoracic Spine ManipulationOther
Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
| Study group | Role | What they receive |
|---|---|---|
| Supine Thoracic Spine Manipulation | Active comparator | Supine (lying face-up on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2) Receives: Other: Supine Thoracic Spine Manipulation |
| Prone Thoracic Spine Manipulation | Active comparator | Prone (lying face down on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2). Receives: Other: Prone Thoracic Spine Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Patient-rated assessment of pain on scale of 0-10
Measured: Baseline (Week 0)
NPRS
Patient-rating of pain on a scale of 0-10
Measured: Change from Week 0 to Week 1
NPRS
Patient-rating of pain on a scale of 0-10
Measured: Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3
Neck Disability Index (NDI)
10 Question patient-rated outcome measures specific to neck disability
Measured: Baseline (Week 0)
NDI
10 Question patient-rated outcome measures specific to neck disability
Measured: Change from Baseline (Week 0) to Week 1
NDI
10 Question patient-rated outcome measures specific to neck disability
Measured: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Measured: Baseline (Week 0)
QuickDASH
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Measured: Change from Week 0 to Week 1
QuickDASH
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Measured: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
Neck Range of Motion (ROM)
Cervical rotation and lateral flexion measured with goniometer.
Measured: Baseline (Week 0)
Neck ROM
Cervical rotation and lateral flexion measured with goniometer.
Measured: Change from Baseline (Week 0) to Week 1
Neck ROM
Cervical rotation and lateral flexion measured with goniometer.
Measured: Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion30 Apr 2015
- Study completion8 Jul 2015
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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Heick, PT, DPT, Principal investigator, A.T. Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245425
- Sponsor's protocol ID
- 2014096
- Status last verified
- Nov 2018
- First submitted
- 17 Sep 2014
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Thoracic Manipulation Techniques to Improve Neck Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02245425
- Acronym / sponsor ID
- 2014096
- Conditions
- Neck Pain
- Keywords
- Neck pain, Thoracic spine manipulation, Range of Motion, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 30 Apr 2015 (actual)
- Study completion
- 8 Jul 2015 (actual)
- First posted
- 19 Sep 2014 (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.
This study is designed to compare the short-term effects of two different thoracic spine thrust manipulation techniques on neck range-of-motion, pain, and self-reported disability in people with neck pain.
The null hypothesis is that there will be no differences between the two manipulation techniques for short-term effects on neck range-of-motion, pain, and self-reported disability in people with neck pain.
Detailed description
Patients will be involved in the study over a 4 week period. Each participant will be asked to attend 4 sessions, with one week in between each session as follows: Week 0 = baseline assessment and treatment 1; Week 1= treatment 2; Week 2 = treatment 3; and week 4 = follow-up assessment.
Patients who meet the inclusion/exclusion criteria will be randomized to either a supine or prone thoracic spine thrust manipulation intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supine Thoracic Spine Manipulation | Active comparator | Other: Supine Thoracic Spine ManipulationSupine (lying face-up on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2) |
| Prone Thoracic Spine Manipulation | Active comparator | Other: Prone Thoracic Spine ManipulationProne (lying face down on the treatment table) thoracic spine thrust manipulation will be given 2 times at 3 treatment sessions (Weeks 0, 1, and 2). |
Who may qualify
- Ages
- 22 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between 22 and 50 years of age
- Primary complaint of neck pain with or without symptoms that spread down into one arm
- Overall rating of neck pain intensity is at least 3/10; the overall rating is the overall average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst pain possible".
- Neck Disability Index (NDI) score > 10 points (measure of self-reported disability with a 0 to 50 point scale where higher scores indicate higher levels of disability).
- Proficient in speaking and reading English to complete outcome questionnaires
Key exclusion criteria (17 listed)
- Neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks
- Neck pain that spreads down into both arms
- Low back pain or thoracic origin of pain
- Nerve root involvement; defined as the presence of two or more neurological findings (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level
- Diagnosis of cervical spine stenosis (narrowing of the central canal that contains the spinal cord)
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 |
|---|---|---|
| Supine Thoracic Spine ManipulationPosition patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician. | Other | Supine Thoracic Spine Manipulation |
| Prone Thoracic Spine ManipulationPosition patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician. | Other | Prone Thoracic Spine Manipulation |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline (Week 0)
Patient-rated assessment of pain on scale of 0-10
NPRS
Time frame: Change from Week 0 to Week 1
Patient-rating of pain on a scale of 0-10
NPRS
Time frame: Change from Baseline (Week 0) and Follow-up (Week 3) and From Week 1 and Week 3
Patient-rating of pain on a scale of 0-10
Neck Disability Index (NDI)
Time frame: Baseline (Week 0)
10 Question patient-rated outcome measures specific to neck disability
NDI
Time frame: Change from Baseline (Week 0) to Week 1
10 Question patient-rated outcome measures specific to neck disability
NDI
Time frame: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
10 Question patient-rated outcome measures specific to neck disability
Shortened Version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH)
Time frame: Baseline (Week 0)
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
QuickDASH
Time frame: Change from Week 0 to Week 1
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
QuickDASH
Time frame: Change from Baseline (Week 0) to Follow-up (Week 3) and from Week 1 to Week 3
11 item patient-rated outcome measure related to disability in the upper extremity with optional work and sport modules.
Neck Range of Motion (ROM)
Time frame: Baseline (Week 0)
Cervical rotation and lateral flexion measured with goniometer.
Neck ROM
Time frame: Change from Baseline (Week 0) to Week 1
Cervical rotation and lateral flexion measured with goniometer.
Neck ROM
Time frame: Change from Baseline (Week 0) to Follow-up (Week 3) and between Week 1 and Week 3
Cervical rotation and lateral flexion measured with goniometer.
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 9 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Neck Pain
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Recruiting
Strain Counter Strain and Conventional Stretching in School-aged Children With Mechanical Neck Pain Due to Prolong Screen Use
Mechanical Neck Pain
Recruiting
Effects of Alexander Technique Versus Feldenkrais Somatic Training in Patients With Text Neck Syndrome
Text Neck Syndrome
Recruiting
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
Chronic Neck Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
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.
John Heick, PT, DPT principal investigator
A.T. Still University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine Thoracic Spine Manipulation and Prone Thoracic Spine Manipulation in people with Neck Pain, run by A.T. Still University of Health Sciences at 1 site 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 5 inclusion and 17 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 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline (Week 0)). The study lists 12 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 9 Nov 2018.