Clinical trial NCT01571674: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Shoulder Pain
Keywords: Cervical
Clinical Prediction Rule
Exercise
Manipulation
Manual therapy
Mobilization
Physical Therapy
Prognosis
Shoulder pain
Thoracic
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
name: University of Colorado, Boulder
name: Northern Navajo Medical Center
name: Gundersen Lutheran Health System
name: Waldron's Peak Physical Therapy
name: Temple University
First posted: 2012-04-05
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Shoulder Pain and Disability Index (SPADI) Score
timeFrame: 1 week, 4 weeks, 6 months
Secondary outcomes:
measure: Change in the Shortened version of the Disability of the Arm, Shoulder and Hand Index (QuickDASH)
timeFrame: 1 week, 4 weeks and 6 months
measure: Global Rating of Change (GROC)
timeFrame: 1 week, 4 weeks, 6 months
measure: Change in the Numeric Pain Rating Scale (NPRS)
timeFrame: 1 week, 4 weeks, 6 months
measure: Change in the Modified Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: 1 week, 4 weeks, 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Boulder
country: United States
facility: Waldron's Peak Physical Therapy
state: Colorado
city: Boulder
country: United States
facility: Wardenburg Health Center at the University of Colorado
state: Colorado
city: Concord
country: United States
facility: Franklin Pierce University
state: New Hampshire
city: Shiprock
country: United States
facility: Northern Navajo Medical Center
state: New Mexico
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Richmond
country: United States
facility: VCUHS- Virginia Commonwealth University Health System
state: Virginia
city: Tacoma
country: United States
facility: University of Puget Sound
state: Washington
city: Onalaska
country: United States
facility: Gundersen Lutheran
state: Wisconsin
Study officials:
affiliation: University of Colorado, Denver
name: Paul Mintken, DPT
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.