Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03090555
Other study ID # c2003.176
Secondary ID
Status Completed
Phase N/A
First received March 14, 2017
Last updated March 20, 2017
Start date January 5, 2004
Est. completion date April 27, 2011

Study information

Verified date March 2017
Source Brooke Army Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the addition of translational manipulation under interscalene block, to a course of orthopaedic manual physical therapy for treatment of adhesive capsulitis of the shoulder. Half the patients will receive a translational manipulation under interscalene block, plus 6 sessions of orthopaedic manual physical therapy. The other half will receive 7 sessions of physical therapy. The investigators hypothesize that the translational manipulation under interscalene block will provide additional benefit beyond the effect of in-clinic orthopaedic manual physical therapy alone.


Description:

Both translational manipulation under interscalene block and in-clinic orthopaedic manual physical therapy are thought to be useful for treating adhesive capsulitis of the shoulder. However, no single intervention for this condition has been proven to be superior to others.

The translational manipulation under interscalene block may improve pain-free motion of the involved shoulder, by releasing tight tissue without the guarding and motion-limiting effect of active muscle tension. The interscalene block prevents the patient from actively contracting the muscles that control the involved shoulder, during the manipulation procedure.

One additional possible benefit of the translational manipulation under interscalene block, is that the technique loads the joint structures--bone, joint capsule--in a safer way with less angular torque than conventional/traditional manipulation under anaesthesia. This minimizes the risk of physical/mechanical harm from the procedure.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date April 27, 2011
Est. primary completion date May 31, 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Military healthcare system beneficiaries 18 years old or older

- Chief complaint of loss of shoulder range of motion

- Passive glenohumeral abduction less than 75 degrees

- Sufficient English-language skills to understand the study protocol.

Exclusion Criteria:

- Clinical diagnosis of diabetes (type I or II)

- Clinically evident and symptomatic rotator cuff tear or cervical radiculopathy

- Pain as the primary impairment (versus limitation of motion as the primary impairment)

- Having contraindications to an interscalene block.

Study Design


Intervention

Procedure:
Translational manipulation
After the patient receives an interscalene block on the affected side, a physical therapist performs a series of thrust manipulations on the participant's affected shoulder. The participant's identified limitations of physiological and accessory motion revealed during manual examination guided the physical therapist's choice of technique, which primarily consisted of an accessory superior to inferior accessory gliding motion performed in a physiological position of limited motion. Additional gliding manipulations in combined movement positions such as increased flexion or abduction plus internal or external rotation were utilized until full passive physiologic motion was restored.
Manual therapy
The first clinic treatment session for all study participants included instruction in the home program of static stretching, resistive exercise, and ice, issue of an illustrated handout and digital video disc detailing the same program, and manual therapy (MT) by a physical therapist that included all indicated grades of non-thrust manipulation of the joints and soft tissue. The MT intervention was targeted toward any identifiable upper quarter pain or movement impairments. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program.

Locations

Country Name City State
United States Brooke Army Medical Center Fort Sam Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Daniel G. Rendeiro

Country where clinical trial is conducted

United States, 

References & Publications (2)

Placzek JD, Roubal PJ, Freeman DC, Kulig K, Nasser S, Pagett BT. Long-term effectiveness of translational manipulation for adhesive capsulitis. Clin Orthop Relat Res. 1998 Nov;(356):181-91. — View Citation

Placzek JD, Roubal PJ, Kulig K, Pagett BT, Wiater JM. Theory and technique of translational manipulation for adhesive capsulitis. Am J Orthop (Belle Mead NJ). 2004 Apr;33(4):173-9. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Shoulder Pain and Disability Index (SPADI) Measure of individual pain and disability baseline, 3 months, 6 months, 12 months, 48 months
Secondary Percent of normal Patient estimate of percent of full functional capacity of involved shoulder 48 months
Secondary Activity limitations Patient estimate of identified activities limited by involved shoulder function 48 months
Secondary Medication use Patient estimate of medications taken due to involved shoulder pain 48 months
See also
  Status Clinical Trial Phase
Recruiting NCT06181461 - Gong's Versus Kaltenborn Mobilization on Pain, Range of Motion and Function in Adhesive Capsulitis N/A
Recruiting NCT03676829 - Embolization for the Treatment of Pain Secondary to Adhesive Capsulitis Phase 1/Phase 2
Completed NCT05897866 - Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM) N/A
Completed NCT04747938 - Frozen Shoulder Treated by Energy Accumulator N/A
Recruiting NCT05979974 - High Energy Density Pulse Electromagnetic Field for Patients With Frozen Shoulder N/A
Completed NCT02169206 - Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position N/A
Enrolling by invitation NCT03861923 - Dry Needling for Shoulder Adhesive Capsulitis N/A
Completed NCT06391567 - Balance in People With Frozen Shoulder
Not yet recruiting NCT05956171 - The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder N/A
Completed NCT03320200 - A Central Nervous System Focused Treatment Approach for Frozen Shoulder N/A
Recruiting NCT04738253 - Correlation Between Ultrasonography Finding and Shoulder Range of Motion in Stroke Patients
Not yet recruiting NCT06129006 - Ultrasound Guided Shoulder Anterior Capsular Infiltration Plus Hydrodilatation With Steroid Versus Hyalase in Patients With Frozen Shoulder N/A
Completed NCT02944526 - The Effect of 3 Ropivacaine Suprascapular Nerve Blocks in Subacute Adhesive Capsulitis: a Randomized Controlled Trial Phase 4
Recruiting NCT02283996 - Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment Phase 4
Completed NCT02006719 - Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT01483963 - AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder Phase 2
Completed NCT04369144 - Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder N/A
Completed NCT03951896 - Efficacy of Platelet Rich Plasma Injections in Patients With Adhesive Capsulitis of the Shoulder Early Phase 1
Completed NCT05993000 - Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial N/A
Completed NCT05372497 - Central Nervous System Focused Therapy in Frozen Shoulder N/A