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

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Pain
• Intervention / Treatment: Procedure: Manipulation + Exercise Group; Procedure: Exercise Group

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
    • Boulder, Colorado, United States, 80303
      • Waldron's Peak Physical Therapy
    • Boulder, Colorado, United States, 80303
      • Wardenburg Health Center at the University of Colorado
  • New Hampshire
    • Concord, New Hampshire, United States, 03461
      • Franklin Pierce University
  • New Mexico
    • Shiprock, New Mexico, United States, 87420
      • Northern Navajo Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
  • Virginia
    • Richmond, Virginia, United States, 23298
      • VCUHS- Virginia Commonwealth University Health System
  • Washington
    • Tacoma, Washington, United States, 98416
      • University of Puget Sound
  • Wisconsin
    • Onalaska, Wisconsin, United States, 54650
      • Gundersen Lutheran

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Procedure: Exercise Group; First 2 sessions ◦ Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program
Active Comparator: Exercise Group; The exercise group will be treated with a stretching and strengthening program.	Procedure: Exercise Group; First 2 sessions ◦ Active Range of Motion Exercises for the cervicothoracic spine Final 6 sessions ◦ Evidence based shoulder girdle exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Temple University; Virginia Commonwealth University; University of Colorado, Boulder; Gundersen Lutheran Health System; Northern Navajo Medical Center; Waldron's Peak Physical Therapy
• Investigators: Principal Investigator: Paul Mintken, DPT, University of Colorado, Denver

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 30, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Estimate): May 17, 2016
• Last Update Submitted That Met QC Criteria: May 13, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Prognosis; Physical Therapy; Cervical; Manual therapy; Mobilization; Thoracic; Shoulder pain; Clinical Prediction Rule; Manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 12-0040 (Other Identifier: UNC - Biomedical IRB)