Shoulder PainPhase 2/3NCT01571674
Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
A Phase 2/3 study testing Manipulation + Exercise Group and Exercise Group in people with Shoulder Pain, run by University of Colorado, Denver at 9 sites in United States.
Trial summary
The purpose of this study is to determine the validity of previously identified prognostic variables that may identify patients with shoulder pain that are likely to benefit from cervicothoracic spine manipulation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Manipulation + Exercise Group and Exercise Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 9 sitesUnited States
- Study dates
- Jan 2012to Jun 2015
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary complaint of shoulder pain (defined as pain between the neck and the elbow at rest or during movement of the upper arm, see diagram to the right)
- Age between 18-65 years old
- Shoulder Pain and Disability (SPADI) score > 20 points
Who cannot join
- Medical red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- Acute fractures in the shoulder region.
- Acute severe trauma in the cervical or thoracic region in the last 6 weeks.
- Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
- Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
Show all 13Show fewer
- Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
- Muscle weakness involving a major muscle group of the upper extremity
- Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps brachii reflexes)
- Diminished or absent sensation to pinprick in any upper extremity dermatome
- Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation.
- Insufficient English language skills to complete all questionnaires
- Inability to comply with treatment and follow-up schedule
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Colorado Denver
Aurora, Colorado, 80045
Waldron's Peak Physical Therapy
Boulder, Colorado, 80303
Wardenburg Health Center at the University of Colorado
Boulder, Colorado, 80303
Franklin Pierce University
Concord, New Hampshire, 03461
Gundersen Lutheran
Onalaska, Wisconsin, 54650
Temple University
Philadelphia, Pennsylvania, 19140
VCUHS- Virginia Commonwealth University Health System
Richmond, Virginia, 23298
Northern Navajo Medical Center
Shiprock, New Mexico, 87420
University of Puget Sound
Tacoma, Washington, 98416
About this study
The purpose of this study is to determine the validity of previously identified prognostic variables that may identify patients with shoulder pain that are likely to benefit from cervicothoracic spine manipulation.
Read the detailed description
The investigators have recently identified prognostic variables in a preliminary Clinical Prediction Rule (CPR) that are purported to identify patients with shoulder pain who respond favorably to cervicothoracic spinal manipulative therapy (SMT) and daily home exercises of cervical and thoracic active range of motion exercises. These prognostic variables have been identified in a single study, and therefore it is not known if these factors will be valid in a different group of patients, even ones with similar characteristics as those used in the investigators' initial exploratory study. Further study of these identified factors is needed for validation in an independent sample of patients, which will improve generalizability for clinical practice. In this study, patients with a primary complaint of shoulder pain will be randomly assigned to receive cervicothoracic spine manipulation followed by therapeutic exercises or therapeutic exercise alone. If the variables are in fact meaningful, patients who exhibit 3 or more of the identified prognostic variables and receive cervicothoracic SMT should experience improved outcomes compared to patients who have less than 3 of these variables and receive the same intervention. Additionally, patients who exhibit 3 or more of the identified variables that receive cervicothoracic SMT should also have superior outcomes to patients who exhibit 3 or more of the identified variables and receive an alternate intervention (exercise only). Finally, the investigators will determine if the addition of cervicothoracic SMT to exercise improves outcomes as compared to exercise alone.
- Conditions
- Shoulder Pain
- Being tested
- Manipulation + Exercise Group, Exercise Group
- Keywords
- Cervical, Clinical Prediction Rule, Exercise, Manipulation, Manual therapy, Mobilization, Physical Therapy, Prognosis, Shoulder pain, Thoracic
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation + Exercise GroupProcedure or surgery
First 2 sessions
- High-velocity, low-amplitude manipulations to the thoracic spine.
- Low-velocity mid to end-range mobilizations to the cervical spine.
- Active Range of Motion Exercises for the cervicothoracic spine
Final 6 sessions
◦ Evidence based shoulder girdle exercise program
Exercise GroupProcedure or surgery
First 2 sessions
◦ Active Range of Motion Exercises for the cervicothoracic spine
Final 6 sessions
◦ Evidence based shoulder girdle exercise program
| Study group | Role | What they receive |
|---|---|---|
| Manipulation + Exercise Group | Experimental | The treatment received by the manipulation+exercise group will differ from the exercise group for the first week only (two treatment sessions). During the first two sessions, patients in the manipulation+exercise group will receive cervicothoracic spine manipulations and range of motion (ROM) exercises only. Beginning on the third session these patients will receive the same exercise program as the exercise group. Receives: Procedure: Manipulation + Exercise Group; Procedure: Exercise Group |
| Exercise Group | Active comparator | The exercise group will be treated with a stretching and strengthening program. Receives: Procedure: Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index (SPADI) Score
The SPADI is a 13 item questionnaire. The pain domain consists of five questions and the disability domain consists of eight. Each question refers to the past week.
Measured: 1 week, 4 weeks, 6 months
Secondary outcomes (4)
Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH)
The QuickDASH4 is an eleven-item questionnaire that addresses symptoms and physical function in people with any or multiple disorders involving the upper limb.
Measured: 1 week, 4 weeks and 6 months
Global Rating of Change (GROC)
The GROC asks patients to rate whether their health condition has improved or deteriorated over time to determine the efficacy of a particular treatment. Scores range from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively.
Measured: 1 week, 4 weeks, 6 months
Change in the Numeric Pain Rating Scale (NPRS)
An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase "No Pain" and on the right with the phrase "Worst Imaginable Pain". Patients rate their current level of pain and their worst and least amount of pain in the last 24 hours. The average of the three ratings or any single rating may be used to represent the patient's level of pain.
Measured: 1 week, 4 weeks, 6 months
Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ)
The FABQ is a 16-item questionnaire designed to quantify fear and avoidance beliefs in patients with musculoskeletal disorders. The FABQ has two sub-scales, a 7-item scale to measure fear-avoidance beliefs about work and a 4-item scale to measure fear-avoidance beliefs about physical activity. Each item is scored from 0-6 with possible scores ranging between 0-24 and 0-42 for the physical activity and work subscales, respectively, with higher scores representing increased fear-avoidance beliefs.
Measured: 1 week, 4 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University, University of Colorado, Boulder, Northern Navajo Medical Center, Gundersen Lutheran Health System, Waldron's Peak Physical Therapy, Temple University
- Responsible party
- Sponsor
- Investigators
- Paul Mintken, DPT, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571674
- Sponsor's protocol ID
- 12-0040
- Status last verified
- May 2016
- First submitted
- 30 Mar 2012
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010 Jul;91(7):1128-36. doi: 10.1016/j.apmr.2010.04.009.
PubMed 20599053Mintken PE, Cleland JA, Carpenter KJ, Bieniek ML, Keirns M, Whitman JM. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010 Jan;90(1):26-42. doi: 10.2522/ptj.20090095. Epub 2009 Dec 3.
PubMed 19959652Mintken PE, DeRosa C, Little T, Smith B; American Academy of Orthopaedic Manual Physical Therapists. AAOMPT clinical guidelines: A model for standardizing manipulation terminology in physical therapy practice. J Orthop Sports Phys Ther. 2008 Mar;38(3):A1-6. doi: 10.2519/jospt.2008.0301. Epub 2008 Feb 29.
PubMed 18349498Bergman GJ, Winters JC, Groenier KH, Pool JJ, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial. Ann Intern Med. 2004 Sep 21;141(6):432-9. doi: 10.7326/0003-4819-141-6-200409210-00008.
PubMed 15381516Strunce JB, Walker MJ, Boyles RE, Young BA. The immediate effects of thoracic spine and rib manipulation on subjects with primary complaints of shoulder pain. J Man Manip Ther. 2009;17(4):230-6. doi: 10.1179/106698109791352102.
PubMed 20140154Boyles RE, Ritland BM, Miracle BM, Barclay DM, Faul MS, Moore JH, Koppenhaver SL, Wainner RS. The short-term effects of thoracic spine thrust manipulation on patients with shoulder impingement syndrome. Man Ther. 2009 Aug;14(4):375-80. doi: 10.1016/j.math.2008.05.005. Epub 2008 Aug 15.
PubMed 18703377Walser RF, Meserve BB, Boucher TR. The effectiveness of thoracic spine manipulation for the management of musculoskeletal conditions: a systematic review and meta-analysis of randomized clinical trials. J Man Manip Ther. 2009;17(4):237-46. doi: 10.1179/106698109791352085.
PubMed 20140155Failla MJ, Mintken PE, McDevitt AW, Michener LA. Trajectory of patient-rated outcomes and association with patient acceptable symptom state in patients with musculoskeletal shoulder pain. J Man Manip Ther. 2023 Aug;31(4):279-286. doi: 10.1080/10669817.2022.2137350. Epub 2022 Oct 27.
PubMed 36300352Mintken PE, McDevitt AW, Michener LA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Cleland JA. Examination of the Validity of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation. J Orthop Sports Phys Ther. 2017 Apr;47(4):252-260. doi: 10.2519/jospt.2017.7100. Epub 2017 Mar 3.
PubMed 28257617Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.
PubMed 27477473
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01571674
- Acronym / sponsor ID
- 12-0040
- Conditions
- Shoulder Pain
- Keywords
- Cervical, Clinical Prediction Rule, Exercise, Manipulation, Manual therapy, Mobilization, Physical Therapy, Prognosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University, University of Colorado, Boulder, Northern Navajo Medical Center, Gundersen Lutheran Health System, Waldron's Peak Physical Therapy, Temple University
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 5 Apr 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.
The purpose of this study is to determine the validity of previously identified prognostic variables that may identify patients with shoulder pain that are likely to benefit from cervicothoracic spine manipulation.
Detailed description
The investigators have recently identified prognostic variables in a preliminary Clinical Prediction Rule (CPR) that are purported to identify patients with shoulder pain who respond favorably to cervicothoracic spinal manipulative therapy (SMT) and daily home exercises of cervical and thoracic active range of motion exercises. These prognostic variables have been identified in a single study, and therefore it is not known if these factors will be valid in a different group of patients, even ones with similar characteristics as those used in the investigators' initial exploratory study. Further study of these identified factors is needed for validation in an independent sample of patients, which will improve generalizability for clinical practice. In this study, patients with a primary complaint of shoulder pain will be randomly assigned to receive cervicothoracic spine manipulation followed by therapeutic exercises or therapeutic exercise alone. If the variables are in fact meaningful, patients who exhibit 3 or more of the identified prognostic variables and receive cervicothoracic SMT should experience improved outcomes compared to patients who have less than 3 of these variables and receive the same intervention. Additionally, patients who exhibit 3 or more of the identified variables that receive cervicothoracic SMT should also have superior outcomes to patients who exhibit 3 or more of the identified variables and receive an alternate intervention (exercise only). Finally, the investigators will determine if the addition of cervicothoracic SMT to exercise improves outcomes as compared to exercise alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation + Exercise Group | Experimental | Procedure: Manipulation + Exercise Group, Procedure: Exercise GroupThe treatment received by the manipulation+exercise group will differ from the exercise group for the first week only (two treatment sessions). During the first two sessions, patients in the manipulation+exercise group will receive cervicothoracic spine manipulations and range of motion (ROM) exercises only. Beginning on the third session these patients will receive the same exercise program as the exercise group. |
| Exercise Group | Active comparator | Procedure: Exercise GroupThe exercise group will be treated with a stretching and strengthening program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary complaint of shoulder pain (defined as pain between the neck and the elbow at rest or during movement of the upper arm, see diagram to the right)
- Age between 18-65 years old
- Shoulder Pain and Disability (SPADI) score > 20 points
Key exclusion criteria (13 listed)
- Medical red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
- Acute fractures in the shoulder region.
- Acute severe trauma in the cervical or thoracic region in the last 6 weeks.
- Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).
- Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
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 |
|---|---|---|
| Manipulation + Exercise GroupFirst 2 sessions * High-velocity, low-amplitude manipulations to the thoracic spine. * Low-velocity mid to end-range mobilizations to the cervical spine. * Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program | Procedure or surgery | Manipulation + Exercise Group |
| Exercise GroupFirst 2 sessions ◦ Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program | Procedure or surgery | Exercise Group, Manipulation + Exercise Group |
Primary outcome
Change in Shoulder Pain and Disability Index (SPADI) Score
Time frame: 1 week, 4 weeks, 6 months
The SPADI is a 13 item questionnaire. The pain domain consists of five questions and the disability domain consists of eight. Each question refers to the past week.
4 secondary outcomes
Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH)
Time frame: 1 week, 4 weeks and 6 months
Global Rating of Change (GROC)
Time frame: 1 week, 4 weeks, 6 months
Change in the Numeric Pain Rating Scale (NPRS)
Time frame: 1 week, 4 weeks, 6 months
Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: 1 week, 4 weeks, 6 months
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 17 May 2016.
- Background: PubMed 20599053Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010 Jul;91(7):1128-36. doi: 10.1016/j.apmr.2010.04.009.
- Background: PubMed 19959652Mintken PE, Cleland JA, Carpenter KJ, Bieniek ML, Keirns M, Whitman JM. Some factors predict successful short-term outcomes in individuals with shoulder pain receiving cervicothoracic manipulation: a single-arm trial. Phys Ther. 2010 Jan;90(1):26-42. doi: 10.2522/ptj.20090095. Epub 2009 Dec 3.
- Background: PubMed 18349498Mintken PE, DeRosa C, Little T, Smith B; American Academy of Orthopaedic Manual Physical Therapists. AAOMPT clinical guidelines: A model for standardizing manipulation terminology in physical therapy practice. J Orthop Sports Phys Ther. 2008 Mar;38(3):A1-6. doi: 10.2519/jospt.2008.0301. Epub 2008 Feb 29.
- Background: PubMed 15381516Bergman GJ, Winters JC, Groenier KH, Pool JJ, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care for patients with shoulder dysfunction and pain: a randomized, controlled trial. Ann Intern Med. 2004 Sep 21;141(6):432-9. doi: 10.7326/0003-4819-141-6-200409210-00008.
- Background: PubMed 20140154Strunce JB, Walker MJ, Boyles RE, Young BA. The immediate effects of thoracic spine and rib manipulation on subjects with primary complaints of shoulder pain. J Man Manip Ther. 2009;17(4):230-6. doi: 10.1179/106698109791352102.
- Background: PubMed 18703377Boyles RE, Ritland BM, Miracle BM, Barclay DM, Faul MS, Moore JH, Koppenhaver SL, Wainner RS. The short-term effects of thoracic spine thrust manipulation on patients with shoulder impingement syndrome. Man Ther. 2009 Aug;14(4):375-80. doi: 10.1016/j.math.2008.05.005. Epub 2008 Aug 15.
- Background: PubMed 20140155Walser RF, Meserve BB, Boucher TR. The effectiveness of thoracic spine manipulation for the management of musculoskeletal conditions: a systematic review and meta-analysis of randomized clinical trials. J Man Manip Ther. 2009;17(4):237-46. doi: 10.1179/106698109791352085.
- Derived from this study: PubMed 36300352Failla MJ, Mintken PE, McDevitt AW, Michener LA. Trajectory of patient-rated outcomes and association with patient acceptable symptom state in patients with musculoskeletal shoulder pain. J Man Manip Ther. 2023 Aug;31(4):279-286. doi: 10.1080/10669817.2022.2137350. Epub 2022 Oct 27.
- Derived from this study: PubMed 28257617Mintken PE, McDevitt AW, Michener LA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Cleland JA. Examination of the Validity of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation. J Orthop Sports Phys Ther. 2017 Apr;47(4):252-260. doi: 10.2519/jospt.2017.7100. Epub 2017 Mar 3.
- Derived from this study: PubMed 27477473Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.
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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.
Paul Mintken, DPT principal investigator
University of Colorado, Denver
9 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 Manipulation + Exercise Group and Exercise Group in people with Shoulder Pain, run by University of Colorado, Denver at 9 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 13 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 17 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Change in Shoulder Pain and Disability Index (SPADI) Score (time frame: 1 week, 4 weeks, 6 months). 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 NCT01571674, which also lists 10 linked publications.
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 17 May 2016.