Validation of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation: A Randomized Clinical Trial

NCT ID: NCT01571674

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-06-30

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.

Conditions

Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manipulation + Exercise Group

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.

Group Type: EXPERIMENTAL

Manipulation + Exercise Group

Intervention Type: PROCEDURE

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 Group

Intervention Type: PROCEDURE

First 2 sessions

◦ Active Range of Motion Exercises for the cervicothoracic spine

Final 6 sessions

◦ Evidence based shoulder girdle exercise program

Exercise Group

The exercise group will be treated with a stretching and strengthening program.

Group Type: ACTIVE_COMPARATOR

Exercise Group

Intervention Type: PROCEDURE

First 2 sessions

◦ Active Range of Motion Exercises for the cervicothoracic spine

Final 6 sessions

◦ Evidence based shoulder girdle exercise program

Interventions

Manipulation + Exercise Group

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

Exercise Group

First 2 sessions

◦ Active Range of Motion Exercises for the cervicothoracic spine

Final 6 sessions

◦ Evidence based shoulder girdle exercise program

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 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)

2. Age between 18-65 years old

3. Shoulder Pain and Disability (SPADI) score > 20 points

Exclusion Criteria

1. 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.)

2. Acute fractures in the shoulder region.

3. Acute severe trauma in the cervical or thoracic region in the last 6 weeks.

4. Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).

5. 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.

6. Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms

7. 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

8. Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation.

9. Insufficient English language skills to complete all questionnaires

10. Inability to comply with treatment and follow-up schedule

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: collaborator

Northern Navajo Medical Center

UNKNOWN

Sponsor Role: collaborator

Gundersen Lutheran Health System

OTHER

Sponsor Role: collaborator

Waldron's Peak Physical Therapy

UNKNOWN

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Mintken, DPT

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Denver

Aurora, Colorado, United States

Waldron's Peak Physical Therapy

Boulder, Colorado, United States

Wardenburg Health Center at the University of Colorado

Boulder, Colorado, United States

Franklin Pierce University

Concord, New Hampshire, United States

Northern Navajo Medical Center

Shiprock, New Mexico, United States

Temple University

Philadelphia, Pennsylvania, United States

VCUHS- Virginia Commonwealth University Health System

Richmond, Virginia, United States

University of Puget Sound

Tacoma, Washington, United States

Gundersen Lutheran

Onalaska, Wisconsin, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20599053 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19959652 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18349498 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15381516 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20140154 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18703377 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20140155 (View on PubMed)

Failla 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.

Reference Type: DERIVED

PMID: 36300352 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28257617 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27477473 (View on PubMed)

Other Identifiers

12-0040

Identifier Type: -

Identifier Source: org_study_id