Shoulder Adhesive CapsulitisTMACSNCT03090555
Translational Manipulation Under Interscalene Block for Adhesive Capsulitis of the Shoulder (TMACS)
A study testing Translational manipulation and Manual therapy in people with Shoulder Adhesive Capsulitis and Frozen Shoulder, run by Daniel G. Rendeiro at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Adhesive Capsulitis, Frozen Shoulder, Adhesive Capsulitis of Shoulder
- What is being tested?
- Translational manipulation and Manual therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2004to 27 Apr 2011
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: The Effectiveness of Translational Manipulation Under Interscalene Block for Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Clinical Trial
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.
Read the detailed 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.
- Being tested
- Translational manipulation, Manual therapy
- Keywords
- adhesive capsulitis, clinical trial, manipulation
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translational manipulationProcedure or surgery
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 therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Translational Manipulation | Experimental | Participants received an interscalene block on the affected side. Then, a physical therapist performed thrust manipulations on the affected shoulder until full passive physiologic motion was restored. These participants returned to the clinic approximately 3 days later for the first of 6 manual therapy (MT) sessions.
The first clinic treatment session included instruction in a 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. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program. Receives: Procedure: Translational manipulation; Procedure: Manual therapy |
| Comparison Group | Active comparator | Participants in the comparison group did not undergo a session of translational manipulation. In order to equalize the number of intervention sessions, members of this group underwent 7 in-clinic sessions of manual therapy (MT). 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 MT by a physical therapist that included all indicated grades of non-thrust manipulation. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program. Receives: Procedure: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index (SPADI)
Measure of individual pain and disability
Measured: baseline, 3 months, 6 months, 12 months, 48 months
Secondary outcomes (3)
Percent of normal
Patient estimate of percent of full functional capacity of involved shoulder
Measured: 48 months
Activity limitations
Patient estimate of identified activities limited by involved shoulder function
Measured: 48 months
Medication use
Patient estimate of medications taken due to involved shoulder pain
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start5 Jan 2004
- Primary completion31 May 2006
- Study completion27 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel G. Rendeiro
- Sponsor type
- US federal agency
- Responsible party
- Sponsor-investigator, Daniel G. Rendeiro, Brooke Army Medical Center
- Investigators
- Daniel G. Rendeiro, DSc, Principal investigator, Army-Baylor University Doctoral Fellowship in Orthopaedic Manual Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090555
- Sponsor's protocol ID
- c2003.176
- Acronym
- TMACS
- Status last verified
- Mar 2017
- First submitted
- 14 Mar 2017
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15132324Placzek 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. doi: 10.1097/00003086-199811000-00025.
PubMed 9917683
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Translational Manipulation Under Interscalene Block for Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03090555
- Acronym / sponsor ID
- TMACS / c2003.176
- Keywords
- adhesive capsulitis, clinical trial, manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Daniel G. RendeiroUS federal agency
- Study start
- 5 Jan 2004 (actual)
- Primary completion
- 31 May 2006 (actual)
- Study completion
- 27 Apr 2011 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Translational Manipulation | Experimental | Procedure: Translational manipulation, Procedure: Manual therapyParticipants received an interscalene block on the affected side. Then, a physical therapist performed thrust manipulations on the affected shoulder until full passive physiologic motion was restored. These participants returned to the clinic approximately 3 days later for the first of 6 manual therapy (MT) sessions. The first clinic treatment session included instruction in a 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. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program. |
| Comparison Group | Active comparator | Procedure: Manual therapyParticipants in the comparison group did not undergo a session of translational manipulation. In order to equalize the number of intervention sessions, members of this group underwent 7 in-clinic sessions of manual therapy (MT). 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 MT by a physical therapist that included all indicated grades of non-thrust manipulation. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translational manipulationAfter 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. | Procedure or surgery | Translational Manipulation |
| Manual therapyThe 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. | Procedure or surgery | Comparison Group, Translational Manipulation |
Primary outcome
Change in Shoulder Pain and Disability Index (SPADI)
Time frame: baseline, 3 months, 6 months, 12 months, 48 months
Measure of individual pain and disability
3 secondary outcomes
Percent of normal
Time frame: 48 months
Activity limitations
Time frame: 48 months
Medication use
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Results publication: PubMed 15132324Placzek 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.
- Results publication: PubMed 9917683Placzek 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. doi: 10.1097/00003086-199811000-00025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel G. Rendeiro, DSc principal investigator
Army-Baylor University Doctoral Fellowship in Orthopaedic Manual Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Translational manipulation and Manual therapy in people with Shoulder Adhesive Capsulitis and Frozen Shoulder, run by Daniel G. Rendeiro at 1 site 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 4 inclusion and 4 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 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Change in Shoulder Pain and Disability Index (SPADI) (time frame: baseline, 3 months, 6 months, 12 months, 48 months). 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 NCT03090555, 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 24 Mar 2017.