Post COVID-19 ConditionNCT05475743
Pain Informed Movement Program in Patients With Post COVID-19 Condition
A study testing Pain Informed Movement program and Standard medical care and leaflet education in people with Post COVID-19 Condition, run by Universidad de Granada at 1 site in Spain.
Trial summary
Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of Pain Informed Movement program in patients with post COVID-19 condition experiencing persistent pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post COVID-19 Condition
- What is being tested?
- Pain Informed Movement program and Standard medical care and leaflet education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 7 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes.
- Agreed to participate.
- Post COVID-19 condition patients meeting the WHO definition for this disease.
- Patients with moderate or severe pain were included, the cut-off point on the Visual Analogical Scale (VAS) being pain greater than or equal to 3.5 cm.
Who cannot join
- Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
- Cognitive impairment that prevented them from understanding and answering the questionnaires.
- Patients suffering from a reinfection with SARS-CoV-2.
- Patients with a history of severe or critical COVID-19 disease severity.
- Patients who had pre-existing chronic pain according to the current IASP definition.
- Patients participating in other studies.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Faculty of Health Sciences. University of Granada.
Granada, Granada, 18071
About this study
Official title: Early Effects of a Pain Informed Movement Program in Patients With Post COVID-19 Condition Experiencing Persistent Pain: a Randomized Control Trial
Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of Pain Informed Movement program in patients with post COVID-19 condition experiencing persistent pain. Through the implementation of this program, the investigators seek to determine whether such intervention can offer significant improvements in reducing pain intensity and interference, catastrophizing, kinesiophobia, and functionality of affected patients.
- Conditions
- Post COVID-19 Condition
- Being tested
- Pain Informed Movement program, Standard medical care and leaflet education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Informed Movement programOther
The patients included in the experimental group attended an 8-week Pain Informed Movement program in addition to standard medical care. The program was led by a physical therapist with experience in treating patients with chronic pain. This program consisted of 2 face-to-face sessions per week, and they were asked to complete two sessions at home weekly. The first face-to-face session was a group session with 3-6 participants, and the second face-to-face session was individual. Both sessions lasted approximately 1 h. In the group sessions, pain neuroscience education was conducted. In the individual sessions, an individualized functional exercise program was performed by each patient, as well as relaxation techniques. Patients were asked to perform the functional exercises and relaxation techniques at home. Participants were asked to record their compliance with the program and their progress.
Standard medical care and leaflet educationOther
In addition to standard medical care, patients assigned to this group received a leaflet with information about the main post COVID-19 condition symptoms. This is a control group that was not controlled or monitored by a therapist.
| Study group | Role | What they receive |
|---|---|---|
| Pain Informed Movement program | Experimental | Not described Receives: Other: Pain Informed Movement program |
| Standard medical care and leaflet education | Active comparator | Not described Receives: Other: Standard medical care and leaflet education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain intensity and pain interference
Pain intensity and interference were quantified using the Brief Pain Inventory (BPI). The section intended to measure pain intensity on the BPI comprises four items, while the section related to pain interference includes seven items. In the intensity section, responses range on a scale from 0 (no pain) to 10 (maximum pain), while in the interference section, responses range from 0 (no interference) to 10 (total interference). To calculate the severity and interference index, the values of the corresponding items are averaged, obtaining values ranging from 0 to 10, with a higher score indicating greater pain intensity and interference. The BPI has been validated as a reliable and valid tool to evaluate these aspects of pain.
Measured: Baseline and at 8 weeks at the end of the intervention
Changes in catastrophization
To evaluate the phenomenon of catastrophizing, the Pain Catastrophizing Scale (PCS) was applied. This instrument consists of 13 statements structured on a 5-point Likert scale ranging from 0 (at no time) to 4 (at all times). The PCS breaks down catastrophizing into three components: feelings of helplessness, magnification of difficulties, and rumination about pain. Each of the items describes different thoughts and emotions that people may experience when in pain. The final score is obtained by summing the scores of all the items, resulting in a score ranging from 0 to 52, with higher scores indicating a higher level of catastrophizing.
Measured: Baseline and at 8 weeks at the end of the intervention
Changes in kinesiophobia
The Tampa Kinesiophobia Scale (TSK) was used to quantify apprehension related to physical activity and the fear of injury (or re-injury). This scale is composed of 11 statements, which are assigned a score on a 4-point scale (1-4). Total scores vary between 11 and 44 points, with higher values being indicative of greater fear of movement and the possibility of (re)injury.
Measured: Baseline and at 8 weeks at the end of the intervention
Changes in functionality
Functionality was assessed using the WHODAS 2.0 tool (World Health Organization Disability Assessment Schedule). It consists in 36 items assessing six main areas of functional ability. This questionnaire uses a 5-point Likert scale for respondents to rate their level of difficulty in six main subscales: Cognition, Mobility, Self-Care, Interpersonal Relationships, Home Life and Community Involvement. Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do). The scores obtained in each area are added to obtain a total score that shows the degree of functional limitation.
Measured: Baseline and at 8 weeks at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start1 Aug 2023
- Primary completion1 Oct 2023
- Study completion7 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post COVID-19 ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
- Investigators
- Marie Carmen Valenza, PhD, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475743
- Sponsor's protocol ID
- DF0097UG
- Status last verified
- Feb 2024
- First submitted
- 26 Jul 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Effects of a Pain Informed Movement Program in Patients With Post COVID-19 Condition Experiencing Persistent Pain: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05475743
- Acronym / sponsor ID
- DF0097UG
- Conditions
- Post COVID-19 Condition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 7 Oct 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who have undergone COVID-19 infection often have long-term sequelae. One of the most prevalent sequelae is pain. The main objective of this research is to investigate the efficacy of Pain Informed Movement program in patients with post COVID-19 condition experiencing persistent pain. Through the implementation of this program, the investigators seek to determine whether such intervention can offer significant improvements in reducing pain intensity and interference, catastrophizing, kinesiophobia, and functionality of affected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pain Informed Movement program | Experimental | Other: Pain Informed Movement program |
| Standard medical care and leaflet education | Active comparator | Other: Standard medical care and leaflet education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both sexes.
- Agreed to participate.
- Post COVID-19 condition patients meeting the WHO definition for this disease.
- Patients with moderate or severe pain were included, the cut-off point on the Visual Analogical Scale (VAS) being pain greater than or equal to 3.5 cm.
Key exclusion criteria (6 listed)
- Pulmonary, cardiac, neurological, vascular, or orthopaedic pathologies that could limit the execution of the evaluation and intervention.
- Cognitive impairment that prevented them from understanding and answering the questionnaires.
- Patients suffering from a reinfection with SARS-CoV-2.
- Patients with a history of severe or critical COVID-19 disease severity.
- Patients who had pre-existing chronic pain according to the current IASP definition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Informed Movement programThe patients included in the experimental group attended an 8-week Pain Informed Movement program in addition to standard medical care. The program was led by a physical therapist with experience in treating patients with chronic pain. This program consisted of 2 face-to-face sessions per week, and they were asked to complete two sessions at home weekly. The first face-to-face session was a group session with 3-6 participants, and the second face-to-face session was individual. Both sessions lasted approximately 1 h. In the group sessions, pain neuroscience education was conducted. In the individual sessions, an individualized functional exercise program was performed by each patient, as well as relaxation techniques. Patients were asked to perform the functional exercises and relaxation techniques at home. Participants were asked to record their compliance with the program and their progress. | Other | Pain Informed Movement program |
| Standard medical care and leaflet educationIn addition to standard medical care, patients assigned to this group received a leaflet with information about the main post COVID-19 condition symptoms. This is a control group that was not controlled or monitored by a therapist. | Other | Standard medical care and leaflet education |
Primary outcome
Changes in pain intensity and pain interference
Time frame: Baseline and at 8 weeks at the end of the intervention
Pain intensity and interference were quantified using the Brief Pain Inventory (BPI). The section intended to measure pain intensity on the BPI comprises four items, while the section related to pain interference includes seven items. In the intensity section, responses range on a scale from 0 (no pain) to 10 (maximum pain), while in the interference section, responses range from 0 (no interference) to 10 (total interference). To calculate the severity and interference index, the values of the corresponding items are averaged, obtaining values ranging from 0 to 10, with a higher score indicating greater pain intensity and interference. The BPI has been validated as a reliable and valid tool to evaluate these aspects of pain.
Changes in catastrophization
Time frame: Baseline and at 8 weeks at the end of the intervention
To evaluate the phenomenon of catastrophizing, the Pain Catastrophizing Scale (PCS) was applied. This instrument consists of 13 statements structured on a 5-point Likert scale ranging from 0 (at no time) to 4 (at all times). The PCS breaks down catastrophizing into three components: feelings of helplessness, magnification of difficulties, and rumination about pain. Each of the items describes different thoughts and emotions that people may experience when in pain. The final score is obtained by summing the scores of all the items, resulting in a score ranging from 0 to 52, with higher scores indicating a higher level of catastrophizing.
Changes in kinesiophobia
Time frame: Baseline and at 8 weeks at the end of the intervention
The Tampa Kinesiophobia Scale (TSK) was used to quantify apprehension related to physical activity and the fear of injury (or re-injury). This scale is composed of 11 statements, which are assigned a score on a 4-point scale (1-4). Total scores vary between 11 and 44 points, with higher values being indicative of greater fear of movement and the possibility of (re)injury.
Changes in functionality
Time frame: Baseline and at 8 weeks at the end of the intervention
Functionality was assessed using the WHODAS 2.0 tool (World Health Organization Disability Assessment Schedule). It consists in 36 items assessing six main areas of functional ability. This questionnaire uses a 5-point Likert scale for respondents to rate their level of difficulty in six main subscales: Cognition, Mobility, Self-Care, Interpersonal Relationships, Home Life and Community Involvement. Response options go from 1 (no difficulty) to 5 (extreme difficulty or can not do). The scores obtained in each area are added to obtain a total score that shows the degree of functional limitation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Carmen Valenza, PhD principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Informed Movement program and Standard medical care and leaflet education in people with Post COVID-19 Condition, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain intensity and pain interference (time frame: Baseline and at 8 weeks at the end of the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.