Efficacy of Pain Science Education Combined With Exercise in Older Adults With Chronic Pain

Overview

As people live longer, long-term pain becomes more common in old age. This type of pain can greatly affect quality of life, reduce independence in daily activities, and diminish overall well-being. This study is part of a project called PReGe, which aims to help older adults age actively and healthily through preventive physiotherapy. The goal is to determine whether a combination of adapted exercise and education about how pain works can help improve the lives of those who suffer from it. The study is supported by the City Council of Salamanca and the Faculty of Nursing and Physiotherapy, and it is carried out in collaboration with the Doctoral Program in Health, Disability, Dependency, and Well-being at the University of Salamanca. The purpose of this study is to determine whether a program that combines physical exercise with educational sessions about pain is more effective for adults over 65 years of age with chronic pain, compared to doing exercise alone. The study aims to find out whether this program improves pain, understanding of pain, mobility, quality of life and Quantitative Electroencephalography (qEEG). This is a medical research study involving participants aged 65 years or older who have experienced pain for more than three months, with an intensity of at least 3 on a 0-to-10 scale. Participants will be randomly assigned to one of three groups, each following a different type of program: Group 1 (Control Group): will perform only adapted physical exercise. Group 2: will perform the same physical exercise and attend educational sessions about pain for 8 weeks. Group 3: will also perform the physical exercise and attend the educational sessions, but for a period of 32 weeks. The study will last for one full year. The exercise program will be supervised by physiotherapists, carried out over 32 weeks, three times per week, with each session lasting approximately 50 minutes. The educational sessions on pain will be brief-about 15 minutes each-and will take place immediately before the exercise sessions. During the first two months, there will be two educational talks per week. After the Christmas break, Group 3 will continue with one talk every two weeks until the end of the study. Three evaluations will be conducted: one before starting the program, another at two months (questionnaires and qEEG only), and a final one at nine months. The initial and final evaluation sessions will last approximately 75 minutes per participant, while the intermediate evaluation of the questionnaires will take about 45 minutes per person. The evaluators who conduct the assessments will not know which group each participant belongs to, to ensure that the results are as objective as possible.

Detailed description

During the course of the study, the following information will be collected, and the following types of tests and assessments will be carried out:

Personal information and medical history.

Physical condition assessments:

1. Functional assessment: the following tests will be conducted: Short Physical Performance Battery (SPPB) and Timed Up \& Go (TUG). 2. Muscle strength assessment: the following tests will be performed: handgrip strength test using a JAMAR dynamometer, five-times sit-to-stand test, and force-velocity profiling using an ADR Encoder. 3. Body composition assessment: will be obtained by bioelectrical impedance analysis (BIA), including measurements of body weight, body mass index (BMI), body fat, visceral fat, appendicular muscle mass, and appendicular mass index.

Questionnaires:

1. Numerical Rating Scale for Pain (NRS) 2. Tampa Scale for Kinesiophobia (TSK-11SV) 3. Pain Catastrophizing Scale 4. Spanish version of the Graded Chronic Pain Scale 5. SF-12 Health Survey

Quantitative Electroencephalography (qEEG): (Spectral domain (brain frequencies, absolute and relative power by band), functional connectivity indices (coherence between regions), topographical or localization indices, complexity or temporal dynamics indices).

All assessments will be administered by a trained and blinded physiotherapist under optimal hygiene and safety conditions, using certified equipment and instruments.

Interventions

• Other Multicomponent training combined with Pain Science Education during 8 weeks
  The intervention included multicomponent training, identical to that of the control group, combined with Pain Science Education lasting eight weeks, with two 15-minute sessions per week, totaling 16 sessions (240 minutes). The educational content covered topics such as pain, subjectivity and context, sensory homunculus and neurotag, the difference between acute and chronic pain, the distinction between damage and pain, the impact of chronic pain on older adults, the biopsychosocial approach to p
• Other Multicomponent training
  The intervention consisted of multicomponent training lasting 32 weeks, with three 50-minute sessions per week. The training included strength, balance, endurance, and mobility exercises, with intensity adjusted according to each participant's individual progression and perceived exertion, using the Borg scale (\<7) as a reference.
• Other Multicomponent training combined with Pain Science Education during 32 weeks
  The intervention combined multicomponent training, identical to the control group, with a 32-week Pain Science Education program. Physical training, three 50-minute sessions per week, included strength, balance, endurance, and mobility exercises, with intensity individualized based on progression and perceived exertion (Borg \<7), supervised by physiotherapists. Education consisted of 24 sessions (15 minutes each): two weekly sessions during the first eight weeks and one session every two weeks

Primary outcome measures

• Numeric Pain Scale (NRS) [Time frame: 32 weeks]

Secondary outcome measures (12)

• Tampa Scale for Kinesiophobia (TSK-11) [Time frame: 32 weeks]
• Pain Catastrophizing Scale (PCS) [Time frame: 32 weeks]
• Graded Chronic Pain Scale (GCPS) [Time frame: 32 weeks]
• SF-12 Health Survey [Time frame: 32 weeks]
• Sociodemographic Variables [Time frame: 32 weeks]
• Short Physical Performance Battery (SPPB) [Time frame: 32 weeks]
• Timed Up & Go (TUG) [Time frame: 32 weeks]
• Handgrip strength (JAMAR dynamometer) [Time frame: 32 weeks]
• Force-velocity profile (ADR Encoder) [Time frame: 32 weeks]
• Body Mass Index (BMI) [Time frame: 32 weeks]
• Body fat percentage [Time frame: 32 weeks]
• Visceral fat [Time frame: 32 weeks]

Eligibility criteria

Inclusion criteria

• Adults over 65 years of age
• History of pain lasting more than 3 months.
• Pain intensity of at least 3 out of 10 on the numeric pain rating scale.
• Ability to understand, speak, and write in Spanish.

Exclusion criteria

• Severe cognitive impairment (score < 24 on the Mini-Mental State Exam).
• Psychiatric disorders.
• Uncontrolled systemic or inflammatory conditions.
• Uncontrolled cardiac conditions.
• Any other circumstances deemed by the investigators that could interfere with the study's purpose or conduct.

Elimination Criteria:

\- Attendance below 85% of total sessions.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Faculty of Nursing and Physiotherapy USAL. Campus Miguel de Unamuno, C. Donantes de Sangre — Salamanca

Publications

• Soares Fonseca L, Pereira Silva J, Bastos Souza M, Gabrich Moraes Campos M, de Oliveira Mascarenhas R, de Jesus Silva H, Souza Maximo Pereira L, Xavier Oliveira M, Cunha Oliveira V. Effectiveness of pharmacological and non-pharmacological therapy on pain intensity and disability in older people with chronic nonspecific low back pain: a systematic review with meta-analysis. Eur Spine J. 2023 Sep;32 PMID 37464184
• Lam N, Green J, Hallas S, Forster A, Crocker TF, Andre D, Ellwood A, Clegg A, Brown L. Mapping review of pain management programmes and psychological therapies for community-dwelling older people living with pain. Eur Geriatr Med. 2024 Feb;15(1):33-45. doi: 10.1007/s41999-023-00871-1. Epub 2023 Oct 18. PMID 37853269
• Zahari Z, Ishak A, Justine M. The effectiveness of patient education in improving pain, disability and quality of life among older people with low back pain: A systematic review. J Back Musculoskelet Rehabil. 2020;33(2):245-254. doi: 10.3233/BMR-181305. PMID 31356191
• Watson JA, Ryan CG, Atkinson G, Williamson P, Ellington D, Whittle R, Dixon J, Martin DJ. Inter-Individual Differences in the Responses to Pain Neuroscience Education in Adults With Chronic Musculoskeletal Pain: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Pain. 2021 Jan;22(1):9-20. doi: 10.1016/j.jpain.2020.03.006. Epub 2020 Jun 22. PMID 32585363
• Nunez-Cortes R, Salazar-Mendez J, Calatayud J, Malfliet A, Lluch E, Mendez-Rebolledo G, Guzman-Munoz E, Lopez-Bueno R, Suso-Marti L. The optimal dose of pain neuroscience education added to an exercise programme for patients with chronic spinal pain: a systematic review and dose-response meta-analysis. Pain. 2024 Jun 1;165(6):1196-1206. doi: 10.1097/j.pain.0000000000003126. Epub 2023 Nov 30. PMID 38047772
• Nijs J, Paul van Wilgen C, Van Oosterwijck J, van Ittersum M, Meeus M. How to explain central sensitization to patients with 'unexplained' chronic musculoskeletal pain: practice guidelines. Man Ther. 2011 Oct;16(5):413-8. doi: 10.1016/j.math.2011.04.005. Epub 2011 May 31. PMID 21632273
• Sluka KA, Frey-Law L, Hoeger Bement M. Exercise-induced pain and analgesia? Underlying mechanisms and clinical translation. Pain. 2018 Sep;159 Suppl 1(Suppl 1):S91-S97. doi: 10.1097/j.pain.0000000000001235. PMID 30113953
• Carville S, Constanti M, Kosky N, Stannard C, Wilkinson C; Guideline Committee. Chronic pain (primary and secondary) in over 16s: summary of NICE guidance. BMJ. 2021 Apr 21;373:n895. doi: 10.1136/bmj.n895. No abstract available. PMID 33883123

Identifiers

NCT: NCT07287501 · USalamancanº1424

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗