Back to resultsValidation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Manipulation + Exercise Group
Exercise Group
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Cervical, Clinical Prediction Rule, Exercise, Manipulation, Manual therapy, Mobilization, Physical Therapy, Prognosis, Shoulder pain, Thoracic
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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
Sites / Locations
- University of Colorado Denver
- Waldron's Peak Physical Therapy
- Wardenburg Health Center at the University of Colorado
- Franklin Pierce University
- Northern Navajo Medical Center
- Temple University
- VCUHS- Virginia Commonwealth University Health System
- University of Puget Sound
- Gundersen Lutheran
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manipulation + Exercise Group
Exercise Group
Arm Description
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.
The exercise group will be treated with a stretching and strengthening program.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT01571674
First Posted
March 30, 2012
Last Updated
May 13, 2016
Sponsor
University of Colorado, Denver
Collaborators
Virginia Commonwealth University, University of Colorado, Boulder, Northern Navajo Medical Center, Gundersen Lutheran Health System, Waldron's Peak Physical Therapy, Temple University
1. Study Identification
Unique Protocol Identification Number
NCT01571674
Brief Title
Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
Official Title
Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
Virginia Commonwealth University, University of Colorado, Boulder, Northern Navajo Medical Center, Gundersen Lutheran Health System, Waldron's Peak Physical Therapy, Temple University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Cervical, Clinical Prediction Rule, Exercise, Manipulation, Manual therapy, Mobilization, Physical Therapy, Prognosis, Shoulder pain, Thoracic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manipulation + Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
The exercise group will be treated with a stretching and strengthening program.
Intervention Type
Procedure
Intervention Name(s)
Manipulation + Exercise Group
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Exercise Group
Intervention Description
First 2 sessions
◦ Active Range of Motion Exercises for the cervicothoracic spine
Final 6 sessions
◦ Evidence based shoulder girdle exercise program
Primary Outcome Measure Information:
Title
Change in Shoulder Pain and Disability Index (SPADI) Score
Description
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.
Time Frame
1 week, 4 weeks, 6 months
Secondary Outcome Measure Information:
Title
Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH)
Description
The QuickDASH4 is an eleven-item questionnaire that addresses symptoms and physical function in people with any or multiple disorders involving the upper limb.
Time Frame
1 week, 4 weeks and 6 months
Title
Global Rating of Change (GROC)
Description
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.
Time Frame
1 week, 4 weeks, 6 months
Title
Change in the Numeric Pain Rating Scale (NPRS)
Description
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.
Time Frame
1 week, 4 weeks, 6 months
Title
Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ)
Description
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.
Time Frame
1 week, 4 weeks, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Mintken, DPT
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Waldron's Peak Physical Therapy
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Wardenburg Health Center at the University of Colorado
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
Franklin Pierce University
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03461
Country
United States
Facility Name
Northern Navajo Medical Center
City
Shiprock
State/Province
New Mexico
ZIP/Postal Code
87420
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
VCUHS- Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Puget Sound
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98416
Country
United States
Facility Name
Gundersen Lutheran
City
Onalaska
State/Province
Wisconsin
ZIP/Postal Code
54650
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20599053
Citation
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.
Results Reference
background
PubMed Identifier
19959652
Citation
Mintken 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.
Results Reference
background
PubMed Identifier
18349498
Citation
Mintken 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.
Results Reference
background
PubMed Identifier
15381516
Citation
Bergman 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.
Results Reference
background
PubMed Identifier
20140154
Citation
Strunce 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.
Results Reference
background
PubMed Identifier
18703377
Citation
Boyles 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.
Results Reference
background
PubMed Identifier
20140155
Citation
Walser 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.
Results Reference
background
PubMed Identifier
28257617
Citation
Mintken 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.
Results Reference
derived
PubMed Identifier
27477473
Citation
Mintken 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.
Results Reference
derived
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Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial
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