Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Objective: To determine whether adding neurodynamic mobilization to early postoperative physiotherapy improves long-term shoulder disability after breast cancer surgery with axillary lymph node dissection. Design: prospective randomized and single blind trial where participants will be randomly allocated into two groups by EPIDAT 3.1 software. Follow-up will be conducted through seven physical therapy assessments: one before surgery, the second one after surgery, the third one post-physical therapy intervention, the fourth one after three months, the fifth after six months and, the sixth one after twelve months, and the seven one after 24 months. Participants: one hundred and forty women, who are undergoing a unilateral breast cancer surgery with axillary lymph node dissection in the Breast Cancer Unit from "PrÃncipe de Asturias" Hospital. Intervention: Early physical therapy to control group and Early physical therapy plus nerve mobilization to intervention group during the three following weeks from surgery. Mechanosensitivity-related symptoms will be assessed using the Upper Limb Neurodynamic Test 1 (ULNT1) before and after surgery. The primary outcome will be shoulder disability, measured with the disability subscale of the Shoulder Pain and Disability Index (SPADI). Secondary outcomes will include shoulder pain related to activities of daily living and the total SPADI score.
After giving their written informed consent, the participants will be summoned to perform the first assessment prior to surgery. Once participants will be discharged from hospital, approximately 3-5 days following the surgery, will be summoned to perform the second assessment. Those who will fulfil the selection criteria will be randomly allocated into two groups by an independent physical therapist. The experimental group will receive Early Physical Therapy plus neural mobilization and the control group will receive Early Physical Therapy. The same physical therapist will carry out all interventions for both groups. The physical therapist who will carry out the randomization process as well as the one who will perform the interventions will be the only two study members aware of group allocation. A third independent and blinded physical therapist will perform the assessments for all participants. Both physical therapists have more than fifteen years' experience in the treatment of breast cancer side effects. The Upper Limb Neurodynamic Test 1 (ULNT1) will be performed before surgery and after surgery to assess mechanosensitivity-related symptoms.The test sequence and the criteria will be followed to identify a positive test will reproduce from de study of de la Rosa.
In both groups, those women who will develop axillary web syndrome symptoms will receive an approach that aim at improving vascular tissue flexibility. If secondary lymphoedema will diagnose then complex decongestive physiotherapy will carry out.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neural mobilization group | Experimental | 3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M) plus neurodynamic techniques consisting of neural tissue longitudinal glide using the Upper Limb Neurodynamic Test 1 (ULNT1), the neurodynamic test sequence for the median nerve, described by Butler and adapted by de la Rosa. With participants in the supine position, the shoulder was abducted and externally rotated, the scapula depressed, the forearm supinated, and the wrist and fingers extended. Mobilization was applied by depressing the scapula, flexing the elbow, and elevating the scapula, extending the elbow, within a pain-free range. The mobilization was applied for 2 minutes. Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks. |
|
| Control group | Active Comparator | 3 to 5 days after surgery, the participants assigned to this group will receive 9 sessions of early physical therapy plus educational program (described in Torres Lacomba M). Each session will be of 40 minutes approximately and will be held 3 sessions a week for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neural mobilization group | Other | See arm/group descriptions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder disability | Shoulder disability will be assessed using the disability subscale of the Shoulder Pain and Disability Index (SPADI), which is a valid and reliable measure in breast cancer survivors. | Before surgery (A0), 3-5 days after surgery (A1), immediately after treatment (A2), and at 3 months (A3), 6 months (A4), 12 months (A5), and 24 months (A6) after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Daily living-related shoulder pain | Daily living-related shoulder pain will be assessed using the SPADI pain subscale. | Before surgery (A0), 3-5 days after surgery (A1), immediately after treatment (A2), and at 3 months (A3), 6 months (A4), 12 months (A5), and 24 months (A6) after treatment |
| Shoulder pain and related disability |
| Measure | Description | Time Frame |
|---|---|---|
| Mechanosensitivity-related symptoms | Mechanosensitivity-related symptoms will be identified using the Upper Limb Neurodynamic Test 1 (ULNT1) | Before surgery (A0) and 3-5 days after surgery (A1) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MarÃa Torres-Lacomba, PhD | University of Alcalá | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MarÃa Torres-Lacomba | Madrid | Madrid | 28024 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20068255 | Background | Torres Lacomba M, Yuste Sanchez MJ, Zapico Goni A, Prieto Merino D, Mayoral del Moral O, Cerezo Tellez E, Minayo Mogollon E. Effectiveness of early physiotherapy to prevent lymphoedema after surgery for breast cancer: randomised, single blinded, clinical trial. BMJ. 2010 Jan 12;340:b5396. doi: 10.1136/bmj.b5396. | |
| 29860136 | Background |
| Label | URL |
|---|---|
| Physiotherapy in women´s health research group | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Two groups: Experimental group & Control group
Not provided
Not provided
As masking techniques, the people responsible for randomization of intervention in each group, the evaluation of subjects and data collection, the analysis of data will be independent. Participants are also masked, since we think they are unable to distinguish between NDG and CG interventions.
| Control group |
| Other |
See arm/group descriptions |
|
Shoulder pain and related disability will be assessed using the total SPADI score. |
| Before surgery (A0), 3-5 days after surgery (A1), immediately after treatment (A2), and at 3 months (A3), 6 months (A4), 12 months (A5), and 24 months (A6) after treatment |
| de la Rosa-Diaz I, Torres-Lacomba M, Acosta-Ramirez P, Orive IG, Nee RJ, de la Villa-Polo P, Andres-Esteban EM, Sanchez-Sanchez B. Protective myoelectric activity at performing upper limb neurodynamic test 1 in breast cancer survivors. A cross-sectional observational study. Musculoskelet Sci Pract. 2018 Aug;36:68-80. doi: 10.1016/j.msksp.2018.05.003. Epub 2018 May 22. |
| 35079831 | Background | Torres-Lacomba M, Prieto-Gomez V, Arranz-Martin B, Ferrandez JC, Yuste-Sanchez MJ, Navarro-Brazalez B, Romay-Barrero H. Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial. Phys Ther. 2022 Mar 1;102(3):pzab314. doi: 10.1093/ptj/pzab314. |
| 26001890 | Background | Torres-Lacomba M, Sanchez-Sanchez B, Prieto-Gomez V, Pacheco-da-Costa S, Yuste-Sanchez MJ, Navarro-Brazalez B, Gutierrez-Ortega C. Spanish cultural adaptation and validation of the shoulder pain and disability index, and the oxford shoulder score after breast cancer surgery. Health Qual Life Outcomes. 2015 May 23;13:63. doi: 10.1186/s12955-015-0256-y. |
| D008722 | Methods |