- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547982
Scapular Mobilization and Proprioceptive Neuromuscular Facilitation on Shoulder Dysfunction After Latissimus Dorsi Flap Breast Reconstruction (PNF)
Study Overview
Status
Conditions
Detailed Description
Several procedures are available for patients undergoing breast reconstruction including pedicled faps such as latissimus dorsi fap (LDF) and transverse rectus abdomens myocutaneous flap (TRAM), as well as free flap requiring microvascular anastomoses like the deep inferior perforator flap (DIEP). Some of these, like LDF, may be combined with implants to provide adequate volume and symmetry.Surgeons employ the latissimus dorsi flap (LDF) for reconstruction of a large variety of breast cancer surgery defects, including quadrantectomy, lumpectomy, modified radical mastectomy, and others.The Latissimus dorsi (LD) muscle, in its interaction with other muscles of the shoulder plays an important role in shoulder adduction, extension, and internal rotation, as well as scapular depression and lateral flexion of the torso, Daily activities that rely on the function of the LD include swimming, climbing stairs, rising with the aid of the arms, and walking on crutches, There is therefore concern that the LD muscle flap procedure may impair shoulder function.The abnormal scapular biomechanics that occur as a result of dysfunction create abnormal scapular positions that decrease normal shoulder function. Therefore, treatment of shoulder dysfunction should include scapular-mobility exercises, or scapular-mobilization (SM) techniques. scapular mobilization and the combined application of techniques resulted in higher achievements, which may be related to increased scapular mobility and thus, the increased range of motion of the glenohumeral joint after scapular mobilization.
Proprioceptive neuromuscular facilitation is an approach to therapeutic exercise that combines functionally based diagonal patterns of movement with techniques of neuromuscular facilitation to evoke motor responses and improve neuromuscular control and function. Limited research is available on the impact combined effect of scapular mobilization and scapular proprioceptive neuromuscular facilitation on shoulder dysfunction after latissimus dorsi flap breast reconstruction Therefore, this study aims to examine the combined therapeutic effect of both techniques on shoulder dysfunction to aid in planning an ideal physical therapy rehabilitation program for shoulder dysfunction after latissimus dorsi flap breast reconstruction.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: madonna isaac, master
- Phone Number: 01289962263
- Email: madonnamagdy76@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- age ranged from 40 to 55 years.
- All patients were female patients suffering from shoulder dysfunction after latissimus dorsi flap breast reconstruction.
- All patients suffering from moderate or severe pain on shoulder joint and limited range of motion that may affect daily activities.
- All patients begun the treatment program 3 to 4 weeks after LDF breast reconstruction.
- Informed consent was obtained from every patient enrolled in the trial.
Exclusion Criteria:
- Current metastases.
- Neurological deficit affecting the shoulder functioning during daily activities.
- Pathology of the shoulder joint including rotator cuff tear adhesive capsulitis and tendinitis.
- Pain or disorder of the cervical spine, elbow, wrist or hand.
- Shoulder surgery, shoulder dislocation fracture acromioclavicular joint osteoarthritis.
- Diabetes.
- Pregnancy.
- Shoulder manipulation under anesthesia, local corticosteroid injection.
- Psychological disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: scapular mobilization and scapular proprioceptive neuromuscular facilitation exercises
eighteen female patients suffering from shoulder dysfunction after latissimus dorsi flap breast reconstruction.
They received scapular mobilization and scapular PNF three session per week for 8 weeks in addition to the traditional physical therapy program.
|
for scapular mobilization, The patient will be laying on the affected forearm on their back.
The therapist is standing before the patient's affected shoulder, placing the index finger of one hand under the medial scapular border, the other hand grasping the superior border of the scapula.
The scapula was moved superiorly and inferiorly for superior and inferior glide, and then the scapula is rotated upward and downward for scapular rotation.
Second, with the patient was in the same position the physiotherapist put the ulnar fingers under the medial scapular border and distracted the scapula from the thorax.
Sets of 10 repetitions were applied performed at a rate of one cycle per 6 s, with a rest interval of 30 seconds between sets.
for PNF is applied by a trained therapist in two diagonals, anterior elevation and posterior depression and posterior elevation and anterior depression with 20 repetitions for each diagonal.
plus tradional physical therapy.
the patients will recieve the traditional physical therapy program in the form of shoulder Range of motion, stretching and strengthening exercises.
|
|
Active Comparator: traditional physical therapy
eighteen female patients suffering from shoulder dysfunction after latissimus dorsi flap breast reconstruction.
They received a traditional physical therapy program, three sessions per week for eight weeks.
|
the patients will recieve the traditional physical therapy program in the form of shoulder Range of motion, stretching and strengthening exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: up to eight weeks
|
The Visual analogue Scale (VAS) will be used for the measurement of pain.
It consists of a line usually 100 mm in length, with anchor descriptors such as (in the pain context) "no pain" and "worst pain imaginable"
|
up to eight weeks
|
|
shoulder and arm disability
Time Frame: up to eight weeks
|
Disability of the arm, shoulder and hand questionnaire will be used to assess shoulder and arm disability.
This system gives a percentage disability score of upper limbs where 0 indicates no disability and 100 indicates complete disability.
The DASH questionnaire consists of 30 questions assessing the impact of upper limb disability (if any) on activities of daily living.
There are also optional sections within the questionnaire examining the effect of their limb function at the work place during sports or when playing musical instruments
|
up to eight weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
shoulder range of motion
Time Frame: up to eight weeks
|
The baseline bubble inclinometer will be used to assess shoulder ROM.
|
up to eight weeks
|
|
scapular upward rotation
Time Frame: up to eight weeks
|
The baseline bubble inclinometer will be used to assess scapular upward rotation
|
up to eight weeks
|
|
scapular downward rotation
Time Frame: up to eight weeks
|
The baseline bubble inclinometer will be used to assess scapular downward rotation
|
up to eight weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/006110
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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