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

Shoulder Pain 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01571674
• Other study ID #: 12-0040
• Status: Enrolling by invitation
• Phase: Phase 2/Phase 3
• First received: March 30, 2012
• Last updated: January 27, 2016
• Start date: June 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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, we will determine if the addition of cervicothoracic SMT to exercise improves outcomes as compared to exercise alone.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• 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
• Exercise Group
First 2 sessions ? Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ? Evidence based shoulder girdle exercise program

Locations

Country	Name	City	State
United States	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	Gundersen Lutheran	Onalaska	Wisconsin
United States	Temple University	Philadelphia	Pennsylvania
United States	VCUHS- Virginia Commonwealth University Health System	Richmond	Virginia
United States	Northern Navajo Medical Center	Shiprock	New Mexico
United States	University of Puget Sound	Tacoma	Washington

Sponsors (7)

Lead Sponsor	Collaborator
University of Colorado, Denver	Gundersen Lutheran Health System, Northern Navajo Medical Center, Temple University, University of Colorado, Boulder, Virginia Commonwealth University, Waldron’s Peak Physical Therapy

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week, 4 weeks, 6 months	No
Secondary	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.	1 week, 4 weeks and 6 months	No
Secondary	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.	1 week, 4 weeks, 6 months	No
Secondary	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.	1 week, 4 weeks, 6 months	No
Secondary	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.	1 week, 4 weeks, 6 months	No