AzTrials
AzTrials

Shoulder PainPhase 2NCT00835302

Development of a Clinical Prediction Rule to Identify Patients With Shoulder Pain Likely to Benefit From Cervicothoracic Manipulation

A Phase 2 study testing Cervicothoracic manipulation in people with Shoulder Pain, run by University of Colorado, Denver at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Shoulder Pain
What is being tested?
Cervicothoracic manipulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
6 sitesUnited States
Study dates
Oct 2006to Mar 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites
  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Wardenburg Health Center

    Boulder, Colorado, 80030

  • Concord Hospital

    Concord, New Hampshire

  • Physiotherapy Associates

    Greenwood Village, Colorado

  • Newton Wellesley Hospital

    Newton, Massachusetts

  • Groves Physical Therapy

    Saint Paul, Minnesota

Other trials in United States

About this study

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.

Read the detailed description

The point prevalence of shoulder symptoms has been reported to range from 20-33% and the incidence of shoulder complaints in the general population is increasing. Furthermore, several authors have reported low rates of perceived recovery (patient reports of "being cured") for patients with a new episode of shoulder or neck pain.3-6 According to Bot et al, less than 25% of patients with a first episode of shoulder pain reported recovery after 3 months, and only 32% stated they had recovered (no longer had symptoms) after 1 year. Other studies have investigated the prognosis of shoulder pain in general practice. Croft et al reported recovery rates of only 21% after 6 months and 49% after 18 months. Van der Windt et al and Winters et al reported recovery rates of 51% and 59% after 12 to 18 months, respectively. Finally, Rekola et al reported that 25% of patients with shoulder or neck pain experienced at least one episode of recurrence within 12 months. These findings suggest that shoulder pain can be recurrent and frequently progresses to the chronic stage.

The Guide to Physical Therapist Practice describes 5 components of patient management; examination, evaluation, diagnosis, prognosis, interventions and outcomes. Information collected during the examination is evaluated in an attempt to improve decision making regarding the most appropriate treatment strategy for the individual patient. Contrary to the medical model which attempts to identify pathology to arrive at a diagnosis, the diagnostic process in physical therapy involves classifying or labeling patients based on functional limitations (restrictions in activities caused by a certain condition) and impairments (loss or abnormality in function such as decreased strength or motion) in an attempt to specifically direct treatment. Clinical decision making regarding treatment involves a certain degree of uncertainty as to which interventions will maximize individual patient outcomes. While the amount of quality evidence supporting physical therapy interventions is increasing, this uncertainty can make it difficult to decide on an appropriate treatment strategy. The American Physical Therapy Association has stated that identifying subgroups of patients who are likely to benefit from specific treatments is a research priority. (APTA) The Guide to Physical Therapist Practice indicates that interventions such as mobilization/manipulation are utilized by physical therapists to manage patients who have shoulder pain. There is growing evidence that impairments in the cervicothoracic spine may contribute to shoulder pain, and that patients with shoulder pain may benefit from manipulation in this region. Manipulation is defined as a manual therapy technique comprising a continuum of skilled passive movements, including small-amplitude/high velocity movements (thrust) and oscillations (non-thrust), that is targeted at joints and soft tissues.

While it is not likely that all patients who have with shoulder pain will benefit from manipulation (thrust and non-thrust) of the cervicothoracic spine, it is possible that a subgroup exists that will experience rapid and dramatic improvement with the use of these manual physical therapy techniques. It is our specific aim to develop a clinical prediction rule (CPR) to identify patients with a primary complaint of shoulder pain who are likely to benefit from cervicothoracic manipulation. The purpose of a CPR is to improve the clinician's accuracy in predicting a diagnosis or an expected outcome. For example, CPRs exist to improve the accuracy of diagnosing ankle fractures in individuals with acute injuries,predict the likelihood of death within four years for individuals with coronary disease, or determine when cervical radiographs are required for patients who have experienced neck trauma. The process of developing and testing a CPR has been described in detail elsewhere. Although CPRs can be developed to improve the accuracy of making a certain diagnosis, the focus of this project is to develop a CPR to predict a certain treatment outcome. The development of a CPR utilizes diagnostic properties of sensitivity, specificity, and positive and negative likelihood ratios, which are based on the individual patient. Thus their interpretation can be readily applied to an individual patient. Development of a CPR to accurately predict which patients with shoulder pain will likely experience a clinically meaningful improvement in pain and function with cervicothoracic spine manipulation before treatment would be immensely helpful for clinicians in the decision-making process. Thus the purpose of this project is to develop a CPR to identify patients with shoulder pain likely to benefit from cervicothoracic spine thrust and non-thrust manipulation.

Conditions
Shoulder Pain
Being tested
Cervicothoracic manipulation
Keywords
Cervical, Thoracic, Manipulation, Mobilization, Clinical prediction rule, Shoulder pain.
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervicothoracic manipulationProcedure or surgery

    Also called Mobilization

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

Study groups in NCT00835302
Study groupRoleWhat they receive
Manipulation + Exercise GroupExperimentalCervicothoracic manipulation and ROM exercises
Receives: Procedure: Cervicothoracic manipulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global Rating of Change (GROC)

    Measured: 7 days

Secondary outcomes (3)
  1. Shoulder Pain and Disability Index (SPADI)

    Measured: 7 days

  2. Numerical Pain Rating Scale

    Measured: 7 days

  3. Painfree Shoulder Range of Motion

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2009 (estimated)
  2. Study startOct 2006
  3. Primary completionDec 2008
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00835302
Sponsor's protocol ID
08-0220
Other IDs
1543340
Status last verified
Feb 2009
First submitted
2 Feb 2009
Last updated
30 Jan 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20599053
  • 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.

    PubMed 19959652

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cervicothoracic manipulation in people with Shoulder Pain, run by University of Colorado, Denver at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Rating of Change (GROC) (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00835302, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2013.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in