Effectiveness of an E-Health System Integrated in a Physical Recovery Program for the Treatment of Pain in the Oncological Population. PaiNEd Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universidad de Granada
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.
Study Overview
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.
Detailed Description
People who have suffered cancer often do not find an adequate therapeutic response for the sequelae derived from its treatments. 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. In this regard, there is a shortage of proposals for certain subgroups of patients who demand special attention. 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 the three study groups: a) physical recovery program + access to the PaiNEd system; b) physical recovery program + traditional biomedical recommendations; c) control group. The evaluation will be carried out at baseline (at the beginning of the study), at 8 weeks (time of completion of the intervention) and at 6 months of follow-up of the patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)
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.
Intervention: Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE) (Other)
Multimodal rehabilitation program + traditional biomedical information
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.
Intervention: Multimodal rehabilitation program + traditional biomedical information (Other)
Control group
Information dossier with recommendations on pain control and dysfunction improvement.
Intervention: Control group (Other)
Outcomes
Primary Outcomes
Change from baseline in Pain on the Visual Analogue scale and Brief Pain Inventory at 2 and 6 months.
Time Frame: Baseline, 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.
Secondary Outcomes
- Changes from baseline in Functional capacity on the The Six-Minute Walk Test at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Pain Catastrophizing Scale 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 Isometric handgrip strength on Hand-held Dynamometry at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in Body composition by using electrical bioimpedance analysis 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 Active shoulder and cervical spine on goniometry at 2 and 6 months.(Baseline, 2 and 6 months.)
- Changes from baseline in stress and inflammatory responses 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.)
- Changes from baseline in Strength endurance deep cervical musculature on cranio-cervical flexion test at 2 and 6 months.(Baseline, 2 and 6 months.)
Investigators
Carolina Fernández Lao
Principal Investigator
Universidad de Granada