Pain Treatment in a Breast Cancer Population. PaiNEd Study.

NCT04877860 | Unknown

• 1 other identifier: PI-0171-2020
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are: 1) To design and implement the PaiNEd system for the evaluation and treatment based on Pain Neuroscience Education (PNE) in cancer survivors with sequelae derived from medical treatments; 2) Study the effectiveness of the PaiNEd system integrated in a multimodal physical recovery program compared to traditional biomedical information. This project aims to first carry out the design and implementation of an e-health system for the evaluation and treatment of pain. A randomized controlled experimental study will be carried out in which 72 breast cancer survivors will be recruited and randomly assigned to three study groups.

Conditions

Breast Cancer

Keywords

E-health; exercise; telehealth; telerehabilitation; pain management; cancer

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.

  The Visual Analogue Scale is used to assess the intensity of spontaneous neck, temporomandibular and shoulder pain. The VAS is a 100 mm line anchored with a '0' at one end representing no pain and '100' at the other end representing the worst pain imaginable.

  Baseline, 2 and 6 months.

Secondary Outcomes (10)

• Changes from baseline in Pain Catastrophizing Scale at 2 and 6 months.

  Baseline, 2 and 6 months.

• Changes from baseline in Central Sensitization Inventory (CSI) at 2 and 6 months.

  Baseline, 2 and 6 months.

• Changes from baseline in Kinesiophobia on the Tampa Scale for Kinesiophobia (TSK-11) at 2 and 6 months.

  Baseline, 2 and 6 months.

• Changes from baseline in Active shoulder and cervical spine on goniometry at 2 and 6 months.

  Baseline, 2 and 6 months.

• Changes from baseline in Quality of life on The European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire at 2 and 6 months.

  Baseline, 2 and 6 months.

Study Arms (3)

Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)

EXPERIMENTAL

Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Access to the PaiNEd system.

Other: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)

Multimodal rehabilitation program + traditional biomedical information

ACTIVE COMPARATOR

Physical recovery program (multimodal) with a duration of 8 weeks. Three weekly sessions on alternate days lasting 60 minutes each one. 4 individual manual therapy sessions (1 session every 2 weeks). Dossier with traditional biomedical recommendations on the management of pain and disability.

Other: Multimodal rehabilitation program + traditional biomedical information

Control group

ACTIVE COMPARATOR

Information dossier with recommendations on pain control and dysfunction improvement.

Other: Control group

Interventions

Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) OTHER

The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Finally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement.

Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)

Multimodal rehabilitation program + traditional biomedical information OTHER

The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises. 4 sessions of myofascial induction. Patients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment.

Multimodal rehabilitation program + traditional biomedical information

Control group OTHER

Waiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects over 18 years of age.
• Having undergone surgery and finished adjuvant treatment (radiotherapy and / or chemotherapy) six months or two years ago.
• Not having active cancer.
• Having pain in the regions related to the tumor area (cervical and / or brachial and / or shoulder), pain ≥ 4 (VAS 0 to 10) for\> 4 weeks
• Present musculoskeletal or functional alterations in the previous regions.

You may not qualify if:

• Identification by the research team of physical or mental impossibility to carry out the tests of the study.
• Suffering from chronic pain or having suffered a previous trauma to the spine, head, temporomandibular joint or upper extremities.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Health Sciences Faculty, University of Granada

Granada, 18071, Spain

RECRUITING

Related Publications (1)

• Fernandez-Gualda MA, Ariza-Vega P, Lozano-Lozano M, Cantarero-Villanueva I, Martin-Martin L, Castro-Martin E, Arroyo-Morales M, Tovar-Martin I, Lopez-Garzon M, Postigo-Martin P, Gonzalez-Santos A, Artacho-Cordon F, Ortiz-Comino L, Galiano-Castillo N, Fernandez-Lao C. Persistent pain management in an oncology population through pain neuroscience education, a multimodal program: PaiNEd randomized clinical trial protocol. PLoS One. 2023 Aug 15;18(8):e0290096. doi: 10.1371/journal.pone.0290096. eCollection 2023.

  PMID: 37582097 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Agnosia; Neoplasms

Interventions

Exercise Therapy; Musculoskeletal Manipulations; Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Complementary Therapies; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Carolina Fernández Lao, PhD

  Health Sciences Faculty, University of Granada

  STUDY DIRECTOR

Central Study Contacts

Carolina Fernández Lao, PhD

CONTACT

958248037; carolinafl@ugr.es

Patrocinio Ariza Vega, PhD

CONTACT

958248032; pariza@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants who meet the inclusion criteria will be randomized into each of the groups using a random number generation program (EPIDAT 4.2, junta de Galicia). The sequence will be placed in an opaque envelope closed by a member outside the investigation and will be opened once the baseline assessment is completed, so the assessment staff will be masked for the randomization of the participants, thus reducing the risk of bias during the evaluation. The blinding of evaluators will be guaranteed by the fact that some members of the group are specialized in the treatment of cancer patients and others in their evaluation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental design with two intervention groups and a control group. Effectiveness study. Intervention group 1: multimodal rehabilitation program + PNE Intervention group 2: multimodal rehabilitation program + traditional biomedical information Control group: Patient waiting list.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: May 7, 2021
• Study Start: April 4, 2022
• Primary Completion: January 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

ES (1)