Relationship Between Pressure Pain Threshold and Pain Intensity, Affect and Disability in CLBP
Primary Purpose
Pain Threshold, Low Back Pain, Pain Measurement
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
segmental stability training
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain Threshold
Eligibility Criteria
Inclusion Criteria:
- Adult males with low back pain with an age group of 18-50 years.
Exclusion Criteria:
- Individuals having low back pain for less than 3 months.
- Individuals with specific underlying pathology as the cause of CLBP. (Active oncological disease, Known disc derangement, cauda equina syndrome, spinal trauma i.e. fracture, neuropathy i.e. sciatica or severe root compression, spinal structural deformity, infection, inflammatory joint disease, spinal stenosis, spondylolysis, spondylolisthesis).
- Individuals having neurological diseases (including central and peripheral diseases); metabolic diseases (i.e. diabetes and hypothyroidism); coagulopathies (i.e. haemophilia).
- Individuals with fibromyalgia syndrome (FMS); myofascial pain syndrome (MPS); allodynia (stroking hyperalgesia).
- Individuals suffering from aphasia or suffering from deafness, blindness or muteness.
- Individuals with skin disease (i.e. psoriasis, scleroderma, leprosy, etc.) or skin lesions (i.e. abrasion/laceration/ bruise) in the low back region.
- Individuals having oral temperature of 100 F or above.
- Individuals who have undergone spinal surgery.
- Individuals scoring 28+ for depression, 20+ for anxiety, 34+ for stress on DASS-21.
- Individuals in whom prone lying causes significant discomfort (i.e. dyspnoea etc.).
- Individuals who do not perceive pressure pain below 10 kg/cm2 during PPT testing.
- Individuals evincing bruising to PPT testing.
Sites / Locations
- Institute of Physical medicine & Rehabilitation, Dow University of Health Sciences
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SEGMENTAL STABILISATION TRAINING (SST)
Arm Description
Segmental Stabilisation Training is an established treatment technique for chronic low back pain
Outcomes
Primary Outcome Measures
Pressure threshold meter
Its a type of force gauge which consists of a rubber-tipped plunger with a surface area of usually 1cm square, connected to the force gauge (body) via a metal rod. The force gauge is usually calibrated in Newtons or Kilograms per cm2 with a range of up to 10 kgs. The exerted pressure on the plunger is transmitted to the gauge through the metal rod, which in turn moves the indicator needle in the clockwise direction with a magnitude corresponding to the force applied. The indicator needle remains in this position until the zeroing knob is pressed, which brings the needle back to its starting position. This allows the examiner to record the last reading of the pressure applied after removing the device from the body.
Visual Analogue scale (VAS) - pain intensity
Visual Analogue scale furnished with specific anchors to measure pain intensity. It is a continuous scale that is considered as a unidimensional measure of the pain experience. It consists of a 100 mm straight line, anchored by descriptors such as 'no pain at all' (0mm) and 'worst pain imaginable' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete. VAS demonstrates ratio-scale properties and it can be adapted to assess dimensions other than intensity such as unpleasantness (affective dimension) associated with pain.
Visual Analogue scale (VAS) - pain affect
Visual analogue scale fine-tuned to measure pain affect with specific anchors. In general, the same technique used for assessing the pain intensity may be used to assess the pain affect. It consists of a 100 mm straight line, anchored by descriptors such as ''not bad at all'' (0mm) and ''the most unpleasant feeling possible for me'' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete.
Disability Rating Index (DRI)
This article focuses on the Disability Rating Index (DRI), a patient-reported outcome measure developed by Salén et al. in 1994, with the aim of measuring the physical disability of respondents within a clinical setting. The DRI evaluates a respondent's disability by assessing activity and participation limitations. It covers 12 non-specific activities of daily life, each one self-rated on a visual analogue scale of 0-100 mm, providing a score of 0-100 for each activity, where 0 represents no difficulty in performing the specific task and 100 indicates an inability to perform the task at all.
Secondary Outcome Measures
Saltin-Grimby Physical Activity Level Scale (SGPALS)
It's a four-level questionnaire to assess leisure-time physical activity (PA). It is anchored by descriptors such as "physically inactive" (0) and "regular hard physical training for competitive sports" (4).
Depression, Anxiety and Stress Scale (DASS-21)
This is a set of three self-report scales designed to measure the emotional states of depression, anxiety & stress. The minimum score lies between 0 - 3 (normal) and the maximum score 14 and above (Extremely Severe). For Anxiety 0 - 3 (normal) and the maximum score 10 and above (Extremely Severe) and For Stress 0 - 7 (normal) and the maximum score 17 and above (Extremely Severe).
Full Information
NCT ID
NCT04482075
First Posted
February 22, 2020
Last Updated
August 17, 2021
Sponsor
Dow University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04482075
Brief Title
Relationship Between Pressure Pain Threshold and Pain Intensity, Affect and Disability in CLBP
Official Title
Cross-modality Matching Between Pressure Pain Threshold and Subjective Ratings of Pain Intensity, Affect and Disability in Patients With Chronic Low Back Pain.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 23, 2020 (Actual)
Study Completion Date
January 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dow University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The association between pressure pain threshold and different aspects of low back pain has garnered attention over the years. However, since most of such studies in the past employed cross sectional designs, a longitudinal study design with follow-up measurements is required to further investigate this relationship. Studying this relationship will not only offer insights into the phenomenon of pain but may also bring us one step closer to achieving the seemingly insurmountable goal of objectively measuring back pain and its different dimensions.
Detailed Description
This study is aimed to examine and evaluate the true extent of the relationship between pressure pain threshold (PPT) and different aspects of somatic pain, by studying the interplay between PPT and different variables, and by further exploring the predictive capability of PPT values to estimate pain intensity, pain affect and disability associated with chronic low back pain (CLBP). In order to estimate these dimensions a calculator based on mathematical equations using different predictive models will be developed. This tool (calculator) will take into account PPT reading from the lower back region and some other variables having confounding effects on PPT and pain, and will be able to predict pain intensity, affect and associated disability with reasonable accuracy. Patients with chronic low back pain shall be the target population and shall be recruited through referrals from the medical Out-Patients Department of Institute of Physical Medicine & Rehabilitation, Dow University of Health Sciences and Department of Rehabilitation Medicine PNS-Shifa Hospital, Karachi, Pakistan after initial screening in accordance with the inclusion and exclusion criteria. Screened patients shall then be briefed about the research project. After explaining the study objectives, procedures, potential benefits and discomforts, written informed consent shall be obtained from the patients. Only upon their agreement shall they become study participants and undergo assessments. The study participants shall receive handouts to document Depression and Anxiety, Pain Intensity, Pain Affect, and Disability. Pressure pain threshold (PPT) shall be measured using a manual Algometer. These measurements shall be followed by a session of physiotherapy treatment, after which Pain Intensity, Pain Affect, and Disability shall be recorded again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Threshold, Low Back Pain, Pain Measurement
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SEGMENTAL STABILISATION TRAINING (SST)
Arm Type
Other
Arm Description
Segmental Stabilisation Training is an established treatment technique for chronic low back pain
Intervention Type
Other
Intervention Name(s)
segmental stability training
Intervention Description
SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.
Primary Outcome Measure Information:
Title
Pressure threshold meter
Description
Its a type of force gauge which consists of a rubber-tipped plunger with a surface area of usually 1cm square, connected to the force gauge (body) via a metal rod. The force gauge is usually calibrated in Newtons or Kilograms per cm2 with a range of up to 10 kgs. The exerted pressure on the plunger is transmitted to the gauge through the metal rod, which in turn moves the indicator needle in the clockwise direction with a magnitude corresponding to the force applied. The indicator needle remains in this position until the zeroing knob is pressed, which brings the needle back to its starting position. This allows the examiner to record the last reading of the pressure applied after removing the device from the body.
Time Frame
Up to 2 weeks
Title
Visual Analogue scale (VAS) - pain intensity
Description
Visual Analogue scale furnished with specific anchors to measure pain intensity. It is a continuous scale that is considered as a unidimensional measure of the pain experience. It consists of a 100 mm straight line, anchored by descriptors such as 'no pain at all' (0mm) and 'worst pain imaginable' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete. VAS demonstrates ratio-scale properties and it can be adapted to assess dimensions other than intensity such as unpleasantness (affective dimension) associated with pain.
Time Frame
Up to 2 weeks
Title
Visual Analogue scale (VAS) - pain affect
Description
Visual analogue scale fine-tuned to measure pain affect with specific anchors. In general, the same technique used for assessing the pain intensity may be used to assess the pain affect. It consists of a 100 mm straight line, anchored by descriptors such as ''not bad at all'' (0mm) and ''the most unpleasant feeling possible for me'' (100mm) at both extremes. The respondent marks the line which corresponds to the current state of pain. Scoring is done with the help of a ruler and the whole process takes about a minute to complete.
Time Frame
Up to 2 weeks
Title
Disability Rating Index (DRI)
Description
This article focuses on the Disability Rating Index (DRI), a patient-reported outcome measure developed by Salén et al. in 1994, with the aim of measuring the physical disability of respondents within a clinical setting. The DRI evaluates a respondent's disability by assessing activity and participation limitations. It covers 12 non-specific activities of daily life, each one self-rated on a visual analogue scale of 0-100 mm, providing a score of 0-100 for each activity, where 0 represents no difficulty in performing the specific task and 100 indicates an inability to perform the task at all.
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Saltin-Grimby Physical Activity Level Scale (SGPALS)
Description
It's a four-level questionnaire to assess leisure-time physical activity (PA). It is anchored by descriptors such as "physically inactive" (0) and "regular hard physical training for competitive sports" (4).
Time Frame
At baseline
Title
Depression, Anxiety and Stress Scale (DASS-21)
Description
This is a set of three self-report scales designed to measure the emotional states of depression, anxiety & stress. The minimum score lies between 0 - 3 (normal) and the maximum score 14 and above (Extremely Severe). For Anxiety 0 - 3 (normal) and the maximum score 10 and above (Extremely Severe) and For Stress 0 - 7 (normal) and the maximum score 17 and above (Extremely Severe).
Time Frame
Up to 2 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Adult males with low back pain with an age group of 18-50 years.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult males with low back pain with an age group of 18-50 years.
Exclusion Criteria:
Individuals having low back pain for less than 3 months.
Individuals with specific underlying pathology as the cause of CLBP. (Active oncological disease, Known disc derangement, cauda equina syndrome, spinal trauma i.e. fracture, neuropathy i.e. sciatica or severe root compression, spinal structural deformity, infection, inflammatory joint disease, spinal stenosis, spondylolysis, spondylolisthesis).
Individuals having neurological diseases (including central and peripheral diseases); metabolic diseases (i.e. diabetes and hypothyroidism); coagulopathies (i.e. haemophilia).
Individuals with fibromyalgia syndrome (FMS); myofascial pain syndrome (MPS); allodynia (stroking hyperalgesia).
Individuals suffering from aphasia or suffering from deafness, blindness or muteness.
Individuals with skin disease (i.e. psoriasis, scleroderma, leprosy, etc.) or skin lesions (i.e. abrasion/laceration/ bruise) in the low back region.
Individuals having oral temperature of 100 F or above.
Individuals who have undergone spinal surgery.
Individuals scoring 28+ for depression, 20+ for anxiety, 34+ for stress on DASS-21.
Individuals in whom prone lying causes significant discomfort (i.e. dyspnoea etc.).
Individuals who do not perceive pressure pain below 10 kg/cm2 during PPT testing.
Individuals evincing bruising to PPT testing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasim Ul Hasanat Qureshi, MSPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shahzad Ali Syed, MSAPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Physical medicine & Rehabilitation, Dow University of Health Sciences
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
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Relationship Between Pressure Pain Threshold and Pain Intensity, Affect and Disability in CLBP
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