NCT00835302

Brief Summary

The investigators seek to develop a clinical prediction rule (CPR) to identify patients with a primary complaint of shoulder pain who are likely to benefit from manual therapy to the neck and upper back regions. Manual therapy will include mobilizations (therapist moves the joints in an oscillating fashion) and manipulations (therapist performs a high velocity low amplitude movement) The investigators hypothesize that a cluster of signs and symptoms from the subject history and physical examination will exist that maximize the accuracy of identifying patients with a primary complaint of shoulder pain likely to benefit from this manual therapy treatment based on a reference standard of patient-reported improvement. The investigators also seek to investigate the psychometric properties (how good a test is), including test retest reliability of a modified version of the Fear Avoidance Beliefs Questionnaire (FABQ) and the shortened Tampa Scale for Kinesiophobia (TSK-11) in patients with shoulder pain. The investigators will also look at the convergent validity (determine if measures that should be related are in reality related) and discriminant validity (show that measures that should not be related are in reality not related) of the modified FABQ and the TSK-11 in patients with shoulder pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 30, 2013

Status Verified

February 1, 2009

Enrollment Period

2.2 years

First QC Date

February 2, 2009

Last Update Submit

January 29, 2013

Conditions

Shoulder Pain

Keywords

CervicalThoracicManipulationMobilizationClinical prediction ruleShoulder pain.

Outcome Measures

Primary Outcomes (1)

  • Global Rating of Change (GROC)

    7 days

Secondary Outcomes (3)

  • Shoulder Pain and Disability Index (SPADI)

    7 days

  • Numerical Pain Rating Scale

    7 days

  • Painfree Shoulder Range of Motion

    7 days

Study Arms (1)

Manipulation + Exercise Group

EXPERIMENTAL

Cervicothoracic manipulation and ROM exercises

Procedure: Cervicothoracic manipulation

Interventions

Cervicothoracic manipulationPROCEDURE

Thrust and non-thrust manipulation to the cervical and thoracic spine

Also known as: Mobilization
Manipulation + Exercise Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 at right)
  • Age between 18-65 years old
  • Shoulder Pain and Disability Index (SPADI) score greater than 20 points (full description of this measure provided in self report measures section)

You may not qualify if:

  • Medical red flags noted in the patient's Medical Screening Questionnaire(i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, weight loss, fever, prolonged history of steroid use, etc.)
  • Acute fractures in the shoulder region.
  • Acute severe trauma to the cervical (neck) or thoracic (upper back) regions 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 as they have only been validated in English.
  • Inability to comply with treatment and follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Wardenburg Health Center

Boulder, Colorado, 80030, United States

Location

Physiotherapy Associates

Greenwood Village, Colorado, United States

Location

Newton Wellesley Hospital

Newton, Massachusetts, United States

Location

Groves Physical Therapy

Saint Paul, Minnesota, United States

Location

Concord Hospital

Concord, New Hampshire, United States

Location

Related Publications (2)

  • 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.

    PMID: 20599053DERIVED

  • 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.

    PMID: 19959652DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2009

First Posted

February 3, 2009

Study Start

October 1, 2006

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

January 30, 2013

Record last verified: 2009-02

Locations

US(6)